NDC 0121-0657-05 - Acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0121-0657
Requested NDC: 0121-0657-05
Package NDCs from labels: 0121-0657-05, 0121-0657-00, 0121-0657-11, 0121-0657-21
Manufacturer: Major Pharmaceuticals
Effective date: 2025-01-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Acetaminophen - Major Pharmaceuticals	Major Pharmaceuticals	2025-01-09	HUMAN OTC DRUG LABEL
Acetaminophen Oral Solution USP Alcohol Free	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-08-12	HUMAN OTC DRUG LABEL
Acetaminophen Oral Solution - Cardinal Health	Cardinal Health	2020-03-13	HUMAN OTC DRUG LABEL
Acetaminophen - Cardinal Health	Cardinal Health	2019-07-01	HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-0657-00	Acetaminophen	10 in 1 CASE	SOLUTION	10	15
0121-0657-00	Acetaminophen	10 in 1 TRAY	SOLUTION	10	15
0121-0657-05	Acetaminophen	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	15
0121-0657-11	Acetaminophen	10 in 1 CASE	SOLUTION	10	15
0121-0657-11	Acetaminophen	10 in 1 TRAY	SOLUTION	10	15
0121-0657-21	Acetaminophen	10 in 1 CASE	SOLUTION	10	15
0121-0657-21	Acetaminophen	10 in 1 TRAY	SOLUTION	10	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0657	ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	15	Current NDC, Legacy NDC, 7 package rows	20240814_6ec12573-03d6-40c1-9945-d345b401e062.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0657-00	ML - Milliliter	0121-0657	e1717ddd-2220-4c37-bf4c-358cc59233d5	1	2017-03-06
0121-0657-05	ML - Milliliter	0121-0657	8ed88d7b-7da9-4476-8acb-44b7546ea729	1	2013-02-13
0121-0657-11	ML - Milliliter	0121-0657	a7c14538-cd3f-460a-9934-c44d6cfa1d56	1	2013-02-13
0121-0657-21	ML - Milliliter	0121-0657	da514a8a-21cf-4316-988f-d31df443bed6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 221 · 4,413 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	FORTUNE PHARMACAL COMPANY LIMITED	33e1bec0-323b-40b7-809a-cb65a71ad0ce	2026-09-17	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier unii: 362O9ITL9D
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	7f445de3-30cf-4bd8-892d-05979cd399e7	2026-09-09	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
dual action	ACETAMINOPHEN, IBUPROFEN	Rite Aid Corporation	54b08d24-d5e9-4111-9d97-329896e8309d	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Leader Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Cardinal Health	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	2026-09-09	Warnings	Exact identifier unii: PDC6A3C0OX
Low Dose Aspirin	ASPIRIN	Strategic Sourcing Services LLC	7ce4807e-7bd5-41f1-a9c7-1f3af6acdc09	2026-09-09	Warnings	Exact identifier application number: M013
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier unii: PDC6A3C0OX
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen Extra Strength	ACETAMINOPHEN	Wal-Mart Stores Inc	78874258-16cc-40b5-9e15-5943eddfce94	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Clear Eyes Nighttime	GLYCERIN	Prestige Brands Holdings, Inc.	af75e2f7-81dd-43e0-a390-b52bbfbebf62	2026-09-08	Warnings	Exact identifier unii: PDC6A3C0OX
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	RARITAN PHARMACEUTICALS	eef00453-9f4f-4a05-bb4e-49b94705b52c	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Pain and Fever Childrens	ACETAMINOPHEN	DOLGENCORP, LLC	c637b39c-a049-43af-a582-fc242e940d85	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	RARITAN PHARMACEUTICALS INC	9819155b-2713-42be-867e-16605e7643d0	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	f7667529-09c0-4603-8080-f236144fac36	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
UP AND UP CHILDRENS ACETAMINOPHEN	ACETAMINOPHEN	Target Corporation	e2989ead-7fdc-4295-bf94-423195775670	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.