Acetaminophen

Product NDC: 69848-008
11-digit product format: 698480008
Labeler code: 69848
Product ID: 69848-008_468e7582-908f-6ec4-e063-6394a90a1653
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Granules USA, Inc
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-01
Substance: ACETAMINOPHEN
Active strength: 500 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 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	69848-008		I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69848-008	69848-008-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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
a51395ea-e038-dc9c-e053-2a95a90a287d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-12-30	EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-09-27	EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-09-25	EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-07-22	EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69848-008-10	Acetaminophen	100 in 1 BOTTLE	TABLET	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69848-008	ACETAMINOPHEN TABLET [GRANULES USA, INC]	6	Current NDC, Legacy NDC, 1 package rows	20241218_a51395ea-e038-dc9c-e053-2a95a90a287d.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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	b4d8860b-d72f-4789-945e-1c6420a8efab	2025-12-02	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	f7b304d8-e37c-4ac6-b4a2-1797b92cb832	2025-12-01	Warnings	Exact identifier application number: M013
Dye FreeInfants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	1a304570-88b6-4c16-a8b4-c064bfa5d95a	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WALGREEN CO.	6c4ab613-a587-4ec4-9986-f1d000bc2d23	2025-12-01	Warnings	Exact identifier application number: M013
WAG HBP Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	ac2f9ce8-e402-4451-a412-e99248a6ecbe	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Day Time NightTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN	WALGREENS CO.	5505217a-9679-4668-bdab-5d4553a47c56	2025-12-01	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	58a371d4-1f00-4fda-8e08-80610c58505a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Non Aspirin Extra Strength	ACETAMINOPHEN	New World Imports, Inc	da05a1a1-35b4-4787-8c56-12e369f18ff0	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	80a699b9-bf5c-4765-9e20-ccbc7e3ace7a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	66244cdb-2680-4fa8-890d-32aefd490038	2025-12-01	Warnings	Exact identifier application number: M013
Family Wellness Childrens Pain Reliever 574	ACETAMINOPHEN	Family Dollar Services, Inc.	902c1136-04d2-41f0-81c6-412663cdf378	2025-12-01	Warnings	Exact identifier application number: M013
WalgreenChildrens Pain Fever	ACETAMINOPHEN	WALGREENS CO.	2f757cde-2604-4ca4-b54e-e444f3757cdd	2025-11-26	Warnings	Exact identifier application number: M013
Walgreen Childrens Pain plus Fever	ACETAMINOPHEN	WALGREENS CO.	29ca2855-3c07-435d-a8e1-2997fcedd088	2025-11-26	Warnings	Exact identifier application number: M013
Walgreens Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	8714d4e6-3a3b-48c8-8ac1-51b933a2ceac	2025-11-26	Warnings	Exact identifier application number: M013
Pain Reliever, 24/7 Life by 7-Eleven	ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44828b89-2563-b233-e063-6294a90ab124	2025-11-26	Warnings	Exact identifier application number: M013
MEMBERS MARK ACETAMINOPHEN	ACETAMINOPHEN	Sam's West Inc	03e831d4-8060-4633-9d02-e77100063fb4	2025-11-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Dissolve Packs	ACETAMINOPHEN	WALGREENS CO.	ea0f265f-7d64-4731-beda-0bb841dd1ad7	2025-11-25	Warnings	Exact identifier application number: M013
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	ATLANTIC BIOLOGICALS CORP.	71a80e13-bda3-40fb-b4e7-45e9985e707c	2025-11-24	Warnings	Exact identifier application number: M013
better living brands childrens fever and pain reliver	ACETAMINOPHEN	BETTER LIVING BRANDS LLC	c13ced61-c491-4fc2-b83f-78c6d9ad8546	2025-11-20	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
198440	acetaminophen 500 MG Oral Tablet	PSN	a51395ea-e038-dc9c-e053-2a95a90a287d	7
198440	acetaminophen 500 MG Oral Tablet	SCD	a51395ea-e038-dc9c-e053-2a95a90a287d	7
198440	APAP 500 MG Oral Tablet	SY	a51395ea-e038-dc9c-e053-2a95a90a287d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69848-008-10	69848000810	100 TABLET in 1 BOTTLE (69848-008-10)	100 tablet	2020-05-01	0000-00-00	No	No	Current