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 39 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ULINE Aspirin	ASPIRIN	ULINE	9b2b053c-11e7-8169-e053-2995a90ae336	2025-09-09	Warnings	Exact identifier application number: M013
Green Guard Chewable Aspirin 81 mg	ASPIRIN	Unifirst First Aid Corporaiton	173a53ca-b6ea-2042-e063-6294a90a8437	2025-09-08	Warnings	Exact identifier application number: M013
Medique Products Chewable Low Dose Aspirin	ASPIRIN	Unifirst First Aid Corporation	17009501-674d-c839-e063-6294a90a59fa	2025-09-08	Warnings	Exact identifier application number: M013
Henry Schein Acetaminophen	ACETAMINOPHEN	Henry Schein, Inc.	a56a5ca1-578c-40cd-90cc-cc4c2dfec847	2025-09-08	Warnings	Exact identifier application number: M013
Henry Schein Acetaminophen	ACETAMINOPHEN	Henry Schein, Inc.	f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Maximum Non-Aspirin	ACETAMINOPHEN	Unifirst First Aid Corporation	30f77d4d-839e-4d96-9f24-0254e6a47b81	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Extra Strength Pain Relief	ASPIRIN. CAFFEINE	Unifirst First Aid Corporation	e729319a-6a2c-bfe6-e053-2a95a90a4620	2025-09-08	Warnings	Exact identifier application number: M013
Medique APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	04805d9c-d959-4870-a185-48b58a880880	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Maximum Strength Non-Aspirin	ACETAMINOPHEN	Unifirst First Aid Corporation	f77c9554-d1c2-1682-e053-6294a90ac572	2025-09-08	Warnings	Exact identifier application number: M013
Medique Back Pain Relief	MAGNESIUM SALICYLATE TETRAHYDRATE	Unifirst First Aid Corporation	e5563a0a-776a-83d4-e053-2a95a90a9500	2025-09-08	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Unifirst First Aid Corporation	56822785-d5fb-4869-971e-5de637c2eda8	2025-09-08	Warnings	Exact identifier application number: M013
Medique Medi-Seltzer Pain Relief	ASPIFIN	Unifirst First Aid Corporation	3d593dee-b932-b611-e063-6294a90ad3b7	2025-09-08	Warnings	Exact identifier application number: M013
Medique Extra Strength APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	f77f8ef5-4aa8-fa80-e053-6394a90a70c2	2025-09-08	Warnings	Exact identifier application number: M013
Medique Pain Off	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Unifirst First Aid Corporation	c2d7af6b-f477-2462-e053-2995a90aff0f	2025-09-08	Warnings	Exact identifier application number: M013
Medique Extra Strength Apap	ACETAMINOPHEN	Unifirst First Aid Corporation	14bcbaf9-76b6-f8ba-e063-6294a90a91f6	2025-09-08	Warnings	Exact identifier application number: M013
Crane Safety XS Non-Aspirin	ACETAMINOPHEN 500 MG	Crane Safety LLC	9626b3b2-c8ba-5a58-e053-2995a90a35c8	2025-09-08	Warnings	Exact identifier application number: M013
Thompson Aspirin	ASPIRIN	Thompson	9623d9c6-f241-bf4a-e053-2a95a90a4eb5	2025-09-08	Warnings	Exact identifier application number: M013
Thompson XS Pain Ache	ASPIRIN, CAFFEINE	Thompson Safety	e87c2874-2a95-6839-e053-2a95a90ad14b	2025-09-08	Warnings	Exact identifier application number: M013
Medique at Home APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	b5582e23-5079-1f2b-e053-2a95a90ad800	2025-09-08	Warnings	Exact identifier application number: M013
Thompson Extra Strength Non-Aspirin	ACETAMINOPHEN	Thompson	f837c31f-24e5-a8df-e053-6394a90a0b36	2025-09-08	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