Acetaminophen

Product NDC: 68071-5239
11-digit product format: 680715239
Labeler code: 68071
Product ID: 68071-5239_2a95afd1-cd26-371c-e063-6294a90a97d4
Type: HUMAN OTC DRUG
Nonproprietary name: Extra Strength Pain Relief
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1989-01-01
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a32f346e-71d0-cc11-e053-2a95a90ae88c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5239-9	2022-02-07	C162847	48780-1	d6a99b39-bd7b-a426-e053-dadaa90af4c2	gc201
68071-5239-9	2022-01-28	C162847	48780-1	d6a99b39-bd7b-a426-e053-dadaa90af4c2	gc201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-5239-3	Acetaminophen	30 in 1 BOTTLE	TABLET	30	7
68071-5239-5	Acetaminophen	45 in 1 BOTTLE	TABLET	45	7
68071-5239-9	Acetaminophen	90 in 1 BOTTLE	TABLET	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5239	ACETAMINOPHEN (EXTRA STRENGTH PAIN RELIEF) TABLET [NUCARE PHARMACEUTICALS,INC.]	7	Current NDC, Legacy NDC, 3 package rows	20250101_a32f346e-71d0-cc11-e053-2a95a90ae88c.zip

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 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2024-10-01	Warnings	Exact identifier application number: M007
Pedia-Lax	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	0e908bea-ebab-44e7-919c-90002e6f5d42	2024-10-01	Warnings	Exact identifier application number: M007
Natural Vegetable Laxative and Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c562e1-4080-44cb-e053-2a95a90a4222	2024-09-25	Warnings	Exact identifier application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENER	SENNOSIDES	Basic Drugs, Inc.	d32b9956-fc04-8d64-e053-2a95a90a17b3	2024-09-14	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	e8be12c5-c591-eadd-e053-2a95a90a431b	2024-09-13	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Proficient Rx LP	5f7f0df4-dabe-4c8f-a2b5-766f20af2f46	2024-09-01	Warnings	Exact identifier application number: M007
Fiber caplets 147	CALCIUM POLYCARBOPHIL	Chain Drug Marketing Association Inc.	17e2a50d-1867-49fe-e063-6394a90a56df	2024-08-27	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE PILLS	SENNOSIDES	TARGET CORPORATION	7cae52ae-931c-3e7c-e053-2991aa0a8396	2024-08-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVE	DOCUSATE SODIUM AND SENNOSIDES	TARGET CORPORATION	7cac99da-8d89-0aee-e053-2991aa0a0fd9	2024-08-22	Warnings	Exact identifier application number: M007
SENNA LAXATIVE	SENNOSIDES 8.6 MG	TARGET CORPORATION	7cab058f-3647-7124-e053-2a91aa0a41bd	2024-08-22	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Padagis Israel Pharmaceuticals Ltd	bce3b245-ec47-4e62-9cad-bb12d0812c18	2024-08-15	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	56f7966a-c95e-3ce3-e054-00144ff88e88	2024-08-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Proficient Rx LP	ccfa095c-77f0-41ff-84f8-e02d983c7c74	2024-08-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Harris Teeter, LLC	1e8e01fc-2c89-9722-e063-6394a90a6acf	2024-07-31	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Best Choice (Valu Merchandisers Company)	d5f90aa1-78e5-491f-b09d-399d54f3def1	2024-07-31	Warnings	Exact identifier application number: M007
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Walgreens	db528659-768a-46e0-a340-9fbcdb25ea5e	2024-07-25	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Walgreens	bfa089a6-4767-45e0-b663-ee7e8949d9a4	2024-07-25	Warnings	Exact identifier application number: M007
Dr. Fibra	PSYLLIUM HUSK	Pharmadel LLC	1a6151c9-e1c4-f0c1-e063-6394a90aad24	2024-07-22	Warnings	Exact identifier application number: M007
BISACODYL	BISCODYL	TARGET CORPORATION	8ed281d5-b17e-e3bb-e053-2995a90a2590	2024-07-15	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	b6f0770e-671d-4965-9275-b1c224d7f06a	2024-07-10	Warnings	Exact identifier application number: M007

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
198440	acetaminophen 500 MG Oral Tablet	PSN	a32f346e-71d0-cc11-e053-2a95a90ae88c	7
198440	acetaminophen 500 MG Oral Tablet	SCD	a32f346e-71d0-cc11-e053-2a95a90ae88c	7
198440	APAP 500 MG Oral Tablet	SY	a32f346e-71d0-cc11-e053-2a95a90ae88c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5239-3	68071523903	30 TABLET in 1 BOTTLE (68071-5239-3)	30 tablet	2020-04-13		No	No	Current
68071-5239-5	68071523905	45 TABLET in 1 BOTTLE (68071-5239-5)	45 tablet	2020-04-13	0000-00-00	No	No	Current
68071-5239-9	68071523909	90 TABLET in 1 BOTTLE (68071-5239-9)	90 tablet	2020-04-13	0000-00-00	No	No	Current