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<CFRGRANULE xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="CFRMergedXML.xsd">
  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>9</VOL>
    <DATE>2001-04-01</DATE>
    <ORIGINALDATE>2001-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Excluded substances.</TITLE>
    <GRANULENUM>1308.22</GRANULENUM>
    <HEADING>Section 1308.22</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 21" SEQ="3">Food and Drugs</PARENT>
      <PARENT HEADING="CHAPTER II" SEQ="2">DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE</PARENT>
      <PARENT HEADING="PART 1308" SEQ="1">SCHEDULES OF CONTROLLED SUBSTANCES</PARENT>
      <PARENT HEADING="" SEQ="0">Excluded Nonnarcotic Substances</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 1308.22</SECTNO>
    <SUBJECT>Excluded substances.</SUBJECT>
    <P>The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):</P>
    <GPOTABLE CDEF="s50,r50,12,xls22,r50,10" COLS="6" OPTS="L2,i1">
      <TTITLE>
        <E T="04">Excluded Nonnarcotic Products</E>
      </TTITLE>
      <BOXHD>
        <CHED H="1">Company</CHED>
        <CHED H="1">Trade name</CHED>
        <CHED H="1">NDC code</CHED>
        <CHED H="1">Form</CHED>
        <CHED H="1">Controlled substance</CHED>
        <CHED H="1">(mg or mg/ml)</CHED>
      </BOXHD>
      <ROW>
        <ENT I="01">Bioline Laboratories </ENT>
        <ENT>Theophed </ENT>
        <ENT>00719-1945 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Goldline Laboratories </ENT>
        <ENT>Guiaphed Elixir </ENT>
        <ENT>00182-1377 </ENT>
        <ENT>EL </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>4.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Goldline Laboratories </ENT>
        <ENT>Tedrigen Tablets </ENT>
        <ENT>00182-0134 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Hawthorne Products Inc </ENT>
        <ENT>Choate's Leg Freeze </ENT>
        <ENT/>
        <ENT>LQ </ENT>
        <ENT>Chloral hydrate </ENT>
        <ENT>246.67</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Parke-Davis &amp; Co </ENT>
        <ENT>Tedral </ENT>
        <ENT>00071-0230 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Parke-Davis &amp; Co </ENT>
        <ENT>Tedral Elixir </ENT>
        <ENT>00071-0242 </ENT>
        <ENT>EX </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>40.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Parke-Davis &amp; Co </ENT>
        <ENT>Tedral S.A. </ENT>
        <ENT>00071-0231 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Parke-Davis &amp; Co </ENT>
        <ENT>Tedral Suspension </ENT>
        <ENT>00071-0237 </ENT>
        <ENT>SU </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>80.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Parmed Pharmacy </ENT>
        <ENT>Asma-Ese </ENT>
        <ENT>00349-2018 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.10</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Rondex Labs </ENT>
        <ENT>Azma-Aids </ENT>
        <ENT>00367-3153 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Smith Kline Consumer </ENT>
        <ENT>Benzedrex </ENT>
        <ENT>49692-0928 </ENT>
        <ENT>IN </ENT>
        <ENT>Propylhexedrine </ENT>
        <ENT>250.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Sterling Drug, Inc </ENT>
        <ENT>Bronkolixir </ENT>
        <ENT>00057-1004 </ENT>
        <ENT>EL </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>0.80</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Sterling Drug, Inc </ENT>
        <ENT>Bronkotabs </ENT>
        <ENT>00057-1005 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Vicks Chemical Co </ENT>
        <ENT>Vicks Inhaler </ENT>
        <ENT>23900-0010 </ENT>
        <ENT>IN </ENT>
        <ENT>I-Desoxyephedrine </ENT>
        <ENT>113.00</ENT>
      </ROW>
      <ROW>
        <ENT I="01">White Hall Labs </ENT>
        <ENT>Primatene (P-tablets) </ENT>
        <ENT>00573-2940 </ENT>
        <ENT>TB </ENT>
        <ENT>Phenobarbital </ENT>
        <ENT>8.00</ENT>
      </ROW>
    </GPOTABLE>
    <CITA TYPE="W">[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]</CITA>
  </SECTION>
  <SUBJGRP>
    <HD SOURCE="HED">Exempt Chemical Preparations</HD>
  </SUBJGRP>
</CFRGRANULE>
