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 48 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	CVS HEALTH CORP	bbc48c9e-7eb8-2c67-e053-2a95a90a8552	2025-02-13	Warnings	Exact identifier application number: M013
Dye Free Infants Pain and Fever	ACETAMINOPHEN	CVS	1fde0f7c-4b5b-ae9c-e063-6394a90afa41	2025-02-13	Warnings	Exact identifier application number: M013
NOTTS - Extra Strength 500 mg	ACETAMINOPHEN	VIVUNT PHARMA LLC	e677f43d-b4ce-e5b0-e053-2a95a90ad67e	2025-02-12	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	LEADER/ Cardinal Health 110, Inc.	b3773f02-02a9-33c8-e053-2995a90a2235	2025-02-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	c9f80d24-bd05-e1ce-e053-2995a90aa646	2025-02-10	Warnings	Exact identifier application number: M013
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c55aa-9932-0a55-e053-2a95a90a3d1e	2025-02-10	Warnings	Exact identifier application number: M013
AeroTab Pain Reliever	PAIN RELIEVER	Aero Healthcare	40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f	2025-02-10	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin Regular Strength	ASPIRIN	Time-Cap Labs, Inc	5fbd8bb3-46f9-4089-9a21-b6af97a06106	2025-02-08	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABS INC	c193dbc0-cc80-4a7c-aa29-457a20edf835	2025-02-08	Warnings	Exact identifier application number: M013
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	22f23aeb-f874-6e54-e063-6394a90a9565	2025-02-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3008928-c555-64ad-e053-2995a90a7307	2025-02-05	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300dfbc-7137-79d1-e053-2995a90a636e	2025-02-05	Warnings	Exact identifier application number: M013
Low dose aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300c30b-ab1a-a1b4-e053-2a95a90a1294	2025-02-05	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d174187-cf89-41ff-9a64-10e0276daf17	2025-02-05	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Bryant Ranch Prepack	c226205d-7c3c-49af-b3e2-fc7b09ad7857	2025-02-05	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	a69fca9d-c0a0-4321-bf03-5c8e99cc07cc	2025-02-04	Warnings	Exact identifier application number: M013
TENSION HEADACHE RELIEF	ACETAMINOPHEN-CAFFEINE	TARGET CORPORATION	8ed1679d-d3a1-11b1-e053-2995a90a61ad	2025-01-31	Warnings	Exact identifier application number: M013
ValuMeds Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cabinet Health P.B.C.	0f864e73-e4b8-4e23-8990-8439ac17bd58	2025-01-31	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN TABLETS 500 MG	WALGREENS	c25bfe92-0196-0489-e053-2995a90abea1	2025-01-30	Warnings	Exact identifier application number: M013
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c3524-3e24-3410-e053-2995a90a73ed	2025-01-30	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