Regular Strength Pain Relief

Product NDC: 68071-4656
Requested package NDC: 68071-4656-5
11-digit product format: 680714656
Labeler code: 68071
Product ID: 68071-4656_1ab856e2-c792-0d29-e063-6294a90a025b
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1989-01-01
Substance: ACETAMINOPHEN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4656	68071-4656-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4656	68071-4656-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4656	68071-4656-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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: Regular Strength Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 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
313782	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
7c73fc75-af9b-177c-e053-2a91aa0ada56	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-13	gc 102
2023-01-30	gc 102
2021-02-17	gc 102
2021-01-29	gc 102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4656-5	Regular Strength Pain Relief	50 in 1 BOTTLE	TABLET	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4656	REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240615_7c73fc75-af9b-177c-e053-2a91aa0ada56.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 54 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Proficient Rx LP	9c186289-e309-45e8-8934-1d0eae0375c2	2024-12-01	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	22f63d62-c941-5b8f-e063-6394a90aeecd	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a7b6318-b7d6-31b1-e053-2991aa0abf25	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	INGLES MARKETS, INC.	27fd288e-c07a-617f-e063-6394a90a17a4	2024-11-28	Warnings	Exact identifier application number: M013
BAYER Aspirin Original, TRAVEL BASIX	ASPIRIN	Lil' Drug Store Products, Inc.	7f5d9ebe-8119-49a2-9380-eca18a5e5e85	2024-11-27	Warnings	Exact identifier application number: M013
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Jones Healthcare Group - Packaging Services, Inc	c4168e4d-3dfc-4e51-a32e-14704cb59c66	2024-11-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief	ACETAMINOPHEN, LIDOCAINE, MENTHOL	Kenvue Brands LLC	2611e984-0dd5-bda1-e063-6394a90a559a	2024-11-26	Warnings	Exact identifier application number: M013
First Aid Only Extra-Strength Non-Aspirin	ACETAMINOPHEN	Acme United Corporation	6891d57a-10a6-53de-e053-2a91aa0ac7c2	2024-11-26	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	MARC GLASSMAN, INC.	c8314910-71ff-5a55-e053-2995a90aafc7	2024-11-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marc Glassman, Inc.	7990ca49-fb30-40fe-9ac4-48e89eac9bb2	2024-11-26	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin Regular Strength	ASPIRIN	Safeway	96359eb6-62bc-4b13-960c-050af99a8c02	2024-11-26	Warnings	Exact identifier application number: M013
ASPIRIN Low Dose	ASPIRIN	Marc Glassman, Inc.	3d519af3-9398-4439-8253-1e5d4612b8e3	2024-11-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	06eabf4b-f8c0-439a-acf1-aa6e3075c717	2024-11-25	Warnings	Exact identifier application number: M013
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier application number: M013
Family Wellness Pain Reliever	ASPIRIN	FAMILY WELLNESS SERVICES, INC.	075e19f4-1a58-aedd-e063-6294a90af708	2024-11-20	Warnings	Exact identifier application number: M013
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier application number: M013
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier application number: M013
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	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	7c73fc75-af9b-177c-e053-2a91aa0ada56	4
313782	acetaminophen 325 MG Oral Tablet	SCD	7c73fc75-af9b-177c-e053-2a91aa0ada56	4
313782	APAP 325 MG Oral Tablet	SY	7c73fc75-af9b-177c-e053-2a91aa0ada56	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4656-5	68071465605	50 TABLET in 1 BOTTLE (68071-4656-5)	50 tablet	2018-12-07	0000-00-00	No	No	Current