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 2 of 211 · 4,204 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UP AND UP CHILDRENS ACETAMINOPHEN	ACETAMINOPHEN	Target Corporation	e2989ead-7fdc-4295-bf94-423195775670	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	WALMART INC.	f9d1dfd1-527f-491d-9188-14886ac70ced	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Pain Relief Extra Strength	ACETAMINOPHEN	Rite Aid Corporation	d846065a-5c39-4f4b-894c-4280acaaf4fa	2026-09-08	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
severe cold and cough daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	3ce8508e-7d9d-4413-858a-8f952e760c01	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
Multi Symptom Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS INC	d9606c9a-31b1-4121-9870-809a05f5b68a	2026-09-08	Warnings	Exact identifier unii: 362O9ITL9D
DESENFRIOL-ITO PLUS	ACETAMINOPHEN	OPMX LLC	5ac41edd-e845-734d-e063-6294a90a990a	2026-09-05	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
DRX CHOICE Regular Strength	ACETAMINOPHEN	Raritan Pharmaceuticals Inc.	8bacb24a-24d0-4175-b3e0-05efb5f5d373	2026-09-05	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	49235f4f-e661-4a83-88ef-b9a956848777	2026-09-04	Warnings	Exact identifier unii: 362O9ITL9D
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	774d2bde-9f57-4ced-800a-cada39c685ed	2026-09-04	Warnings	Exact identifier unii: 362O9ITL9D
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier unii: PDC6A3C0OX
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	REMEDYREPACK INC.	dc2bb7fc-1722-4865-a02c-be5e5c211505	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Feverall Jr. Strength	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3561bbc3-53b0-4857-8b71-39e165ed95ce	2026-09-03	Warnings	Exact identifier unii: 362O9ITL9D
infants pain and fever	ACETAMINOPHEN	CVS Pharmacy	53b06c48-598e-41ad-ac7a-5508c195535c	2026-09-03	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Aspirin Regular Strength	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	2777beea-06d7-4ff5-ae4a-ad7a117dfb62	2026-09-02	Warnings	Exact identifier application number: M013
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	113d92bf-f6c9-cc3d-e063-6294a90af033	2026-09-02	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Extra Strength Pain Reliever	ACETAMINOPHEN	Shield Pharmaceuticals Corp.	78052120-40d8-4a3f-b72f-cc78ca76213b	2026-09-02	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	KROGER COMPANY	7def6781-0881-46bf-ad7a-7a3f23a8d9f7	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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