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Acetaminophen and Codeine Phosphate

NDC 0121-0504 · PAI Holdings, LLC dba PAI Pharma

Generic nameACETAMINOPHEN and CODEINE PHOSPHATE
Dosage formSOLUTION
RouteORAL
Active ingredient(s)ACETAMINOPHEN, CODEINE PHOSPHATE
Strength120; 12 mg/5mL; mg/5mL
Pharmacologic classFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA scheduleCV
Marketing categoryANDA

Packages

0121-0504-40 — 40 TRAY in 1 CASE (0121-0504-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0113-2299 — acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, 0113-2501 — acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, 0113-4500 — acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, 0113-5299 — acetaminophen, ibuprofen, 0113-5300 — Acetaminophen, Ibuprofen, 0113-5305 — acetaminophen, dextromethorphan hydrobromide, 0113-6012 — acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 0113-7019 — acetaminophen, dextromethorphan hydrobromide, 0113-8959 — Acetaminophen, 0113-9523 — Acetaminophen, 0121-0657 — Acetaminophen, 0121-0775 — Guaifenesin and Codeine Phosphate, 0121-0941 — Acetaminophen, 0121-0966 — Acetaminophen, 0121-1008 — ACETAMINOPHEN and CODEINE PHOSPHATE, 0121-1047 — Acetaminophen, 0121-1314 — Acetaminophen, 0121-1544 — HYDROCODONE BITARTRATE and ACETAMINOPHEN, 0121-1550 — Guaifenesin and Codeine Phosphate, 0121-1775 — Guaifenesin and Codeine Phosphate, +3502 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.