Acetaminophen

Product NDC: 55301-519
11-digit product format: 553010519
Labeler code: 55301
Product ID: 55301-519_22c2ed82-d9d4-4ab9-8faa-01267b908876
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: ARMY AND AIR FORCE EXCHANGE SERVICE
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-05-10
Substance: ACETAMINOPHEN
Active strength: 500 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
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f3feca65-adc1-469f-bef6-12c860599abe	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55301-519-51	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	19
55301-519-51	AcetaminophenExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	19
55301-519-60	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	19
55301-519-60	AcetaminophenExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55301-519	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	17	Current NDC, Legacy NDC, 4 package rows	20240608_f3feca65-adc1-469f-bef6-12c860599abe.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 65 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	5411544e-3c2d-4e42-e054-00144ff8d46c	2024-07-10	Warnings	Exact identifier application number: M013
good sense pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L. Perrigo Company	b97c51ad-4953-4491-9ceb-395550eb5296	2024-07-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	065e6f1b-f68c-491a-a157-84961a07e3d9	2024-07-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	3b7b6725-2996-44d3-89a3-032384e7e2ce	2024-07-10	Warnings	Exact identifier application number: M013
equate pain and fever infants	ACETAMINOPHEN	Wal-Mart Stores Inc	8a152c8d-8ae0-4201-8bb9-7b22c3577415	2024-07-10	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WinCo Foods, LLC	3c57498c-86b0-4ba3-881e-c742a2e8ece5	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	WinCo Foods, LLC	c358d1dd-9fcb-4d18-9521-8f898b98a732	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	WinCo Foods, LLC	15430025-f25e-4fe7-b1fe-4eda4684081a	2024-07-09	Warnings	Exact identifier application number: M013
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	WinCo Foods, LLC	0631f003-4852-4034-a1c5-1552804b1660	2024-07-09	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Bryant Ranch Prepack	61ecf3c9-42fa-4ae4-bd3b-694090477b9a	2024-07-09	Warnings	Exact identifier application number: M013
Panadol Cold and Flu NonDrowsy	ACETAMINOPHEN AND PHENYLEPRINE HCL	Haleon US Holdings LLC	fa0ce51f-441d-4409-8617-b3402b00f187	2024-07-08	Warnings	Exact identifier application number: M013
Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	81d4e8f5-2f15-462b-be71-ef05f0b791ab	2024-07-05	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Bryant Ranch Prepack	31a97a6a-e5c8-429a-b497-330f0d84777d	2024-07-05	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	375b2142-3c89-469c-98fd-bd4b63aeaa11	2024-07-05	Warnings	Exact identifier application number: M013
Best Choice Effervescent Pain Reliever 36	ASPIRIN	VALU MERCHANDISERS COMPANY	12f1278e-88b6-0460-e063-6394a90abf0e	2024-07-03	Warnings	Exact identifier application number: M013
Topcare pain and fever	ACETAMINOPHEN	Topco Associates LLC	950b16d5-65db-402d-8ec6-eec9e1e174dd	2024-07-03	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	WALMART INC.	16d5b56f-7e56-0c91-e063-6394a90a4b8e	2024-07-03	Warnings	Exact identifier application number: M013
Acetaminophen and Diphenhydramine hydrochloride	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	16d5786c-2346-f970-e063-6394a90a0a8c	2024-07-03	Warnings	Exact identifier application number: M013
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55301-519-51	55301051951	1 BOTTLE, PLASTIC in 1 CARTON (55301-519-51) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2004-05-10	0000-00-00	No	No	Current
55301-519-60	55301051960	1 BOTTLE, PLASTIC in 1 CARTON (55301-519-60) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2004-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exchange Select 44-519	ARMY AND AIR FORCE EXCHANGE SERVICE \| LNK International, Inc.	2026-05-04	HUMAN OTC DRUG LABEL	19