Acetaminophen

Product NDC: 57237-346
11-digit product format: 572370346
Labeler code: 57237
Product ID: 57237-346_d19afb8f-7095-47fb-ae86-6efa69764655
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-07-09
Substance: ACETAMINOPHEN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-346-01	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
57237-346-10	Acetaminophen	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-346-01	EA - Each	57237-346	2ccb0212-ce31-48f1-bb7c-e48bd05936bd	1	2025-08-11
57237-346-10	EA - Each	57237-346	39d36403-64f2-4dbf-ad05-c27fd026367a	1	2025-11-13

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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1c083e29-8732-4ecd-ab4b-9038acbd0b9d	2025-05-22	Warnings	Exact identifier application number: M013
TYLENOL For Children Plus Adults	ACETAMINOPHEN	Kenvue Brands LLC	5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42	2025-05-21	Warnings	Exact identifier application number: M013
Children Acetaminophen	ACETAMINOPHEN	AARNA USA INC.	25bcb9d5-f388-4ae7-8037-970ffe8d17f0	2025-05-16	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	35478de8-50d0-5d0a-e063-6294a90a88ba	2025-05-16	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	95f4b628-6d35-4f6b-91f9-b2d117f8e821	2025-05-16	Warnings	Exact identifier application number: M013
good neighbor pharmacy childrens pain and fever	ACETAMINOPHEN	Amerisource Bergen	268a789b-8f31-4739-9777-523249cac326	2025-05-13	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE	ASPIRIN LOW DOSE	AARNA USA INC.	347edc8f-6391-b75e-e063-6394a90a1cf5	2025-05-06	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Infants Pain and Fever	ACETAMINOPHEN	Amerisource Bergen	2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2	2025-05-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	34157f6a-3031-4388-e063-6394a90a670f	2025-05-01	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	HF Acquisition Co LLC, DBA HealthFirst	2553d0cb-3f5c-7ea0-e063-6294a90a3cd4	2025-05-01	Warnings, Adverse reactions	Exact identifier application number: M013
Aspirin 81mg Enteric Coated	ASPIRIN	Advanced Rx LLC	606067bb-b07f-444e-9465-d1e187735f3a	2025-05-01	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	33f0e822-28af-9bb2-e063-6294a90a5175	2025-04-29	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	27fcca07-f845-77fe-e063-6394a90aa2f8	2025-04-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	46a6bbb9-ccd1-47a8-9e58-485f71f57063	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	061c91d5-5aa8-4556-a344-197b7e8a10b8	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	c4f0f591-8501-4c6d-bf8e-ca3068ff65b5	2025-04-24	Warnings	Exact identifier application number: M013
Extra Strength No-Pain	ACETAMINOPHEN	Safrel Pharmaceuticals, LLC.	873f01dd-0701-5fd3-e053-2a95a90a6463	2025-04-23	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Chain Drug Consortium	60d4b392-6ed0-4115-8154-24eaf72504a5	2025-04-16	Warnings	Exact identifier application number: M013
Premsyn pms Premenstrual Pain Relief	ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE	Focus Consumer Healthcare, LLC	5b6f6260-69ae-cfeb-e053-2a91aa0a6b49	2025-04-14	Warnings	Exact identifier application number: M013
BackAid Max	ACETAMINOPHEN, PAMABROM	Kobayashi Healthcare International, Inc.	fb9a5647-b7c9-4820-b148-91060e34cb83	2025-04-14	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313782	acetaminophen 325 MG Oral Tablet	PSN	bd5e6804-4df4-4a65-92e4-faa3a0f7c005	4
313782	acetaminophen 325 MG Oral Tablet	SCD	bd5e6804-4df4-4a65-92e4-faa3a0f7c005	4
313782	APAP 325 MG Oral Tablet	SY	bd5e6804-4df4-4a65-92e4-faa3a0f7c005	4
313782	acetaminophen 325 MG Oral Tablet	PSN	19735691-33f3-4e19-85ad-e5f270251ec5	1
313782	acetaminophen 325 MG Oral Tablet	PSN	1f4ac0e6-e986-4c22-8248-0691d64e1a30	1
313782	acetaminophen 325 MG Oral Tablet	PSN	816b65d7-e53f-44c4-a418-074279d4b2af	1
313782	acetaminophen 325 MG Oral Tablet	SCD	19735691-33f3-4e19-85ad-e5f270251ec5	1
313782	acetaminophen 325 MG Oral Tablet	SCD	1f4ac0e6-e986-4c22-8248-0691d64e1a30	1
313782	acetaminophen 325 MG Oral Tablet	SCD	816b65d7-e53f-44c4-a418-074279d4b2af	1
313782	APAP 325 MG Oral Tablet	SY	19735691-33f3-4e19-85ad-e5f270251ec5	1
313782	APAP 325 MG Oral Tablet	SY	1f4ac0e6-e986-4c22-8248-0691d64e1a30	1
313782	APAP 325 MG Oral Tablet	SY	816b65d7-e53f-44c4-a418-074279d4b2af	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
57237-346-01	57237034601	100 TABLET, FILM COATED in 1 BOTTLE (57237-346-01)	2025-07-09	No	No	Current
57237-346-10	57237034610	1000 TABLET, FILM COATED in 1 BOTTLE (57237-346-10)	2025-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen	Rising Pharma Holdings, Inc. \| Elysium Pharmaceuticals Ltd	2026-10-02	HUMAN OTC DRUG LABEL	5
Acetaminophen	Bryant Ranch Prepack	2026-05-08	HUMAN OTC DRUG LABEL	1
Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs \| Elysium Pharmaceuticals Ltd	2026-02-26	HUMAN OTC DRUG LABEL	1
Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs \| Elysium Pharmaceuticals Ltd	2026-02-26	HUMAN OTC DRUG LABEL	1