Acetaminophen

Product NDC: 55301-175
11-digit product format: 553010175
Labeler code: 55301
Product ID: 55301-175_6e7ae313-a4de-4d8d-a4e5-6add736012ef
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ARMY AND AIR FORCE EXCHANGE SERVICE
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-04-02
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	55301-175	55301-175-03	D	Discontinued by firm	2026-10-21
excluded package	package	55301-175	55301-175-06	D	Discontinued by firm	2026-10-21
excluded package	package	55301-175	55301-175-12	D	Discontinued by firm	2026-10-21

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	55301-175-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	55301-175-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	55301-175-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	55301-175-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	55301-175-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	55301-175-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	55301-175-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	55301-175-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	55301-175-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	55301-175-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	55301-175-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	55301-175-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	55301-175-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	55301-175-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	55301-175-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	55301-175-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	55301-175-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	55301-175-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	55301-175-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	55301-175-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	55301-175-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	55301-175-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	55301-175-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	55301-175-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	55301-175-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	55301-175-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	55301-175-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	55301-175-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	55301-175-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	55301-175-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	55301-175-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	55301-175-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	55301-175-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	55301-175-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	55301-175-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	55301-175-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: 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 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
26ae0d0a-34c0-4d16-951a-8d5a463c808b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55301-175-03	Acetaminophen	1 in 1 CARTON	TABLET, FILM COATED	1	26
55301-175-03	Acetaminophen	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	26
55301-175-06	Acetaminophen	2 in 1 CARTON	TABLET, FILM COATED	2	26
55301-175-06	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED	100	26
55301-175-12	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED	100	26
55301-175-12	Acetaminophen	1 in 1 CARTON	TABLET, FILM COATED	1	26
55301-175-15	Acetaminophen	1 in 1 CARTON	TABLET, FILM COATED	1	26
55301-175-15	Acetaminophen	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	26
55301-175-60	Acetaminophen	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	26
55301-175-95	Acetaminophen	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	26

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55301-175	ACETAMINOPHEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]	25	Current NDC, Legacy NDC, 10 package rows	20250406_26ae0d0a-34c0-4d16-951a-8d5a463c808b.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 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier application number: M013
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	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
198440	acetaminophen 500 MG Oral Tablet	PSN	26ae0d0a-34c0-4d16-951a-8d5a463c808b	26
198440	acetaminophen 500 MG Oral Tablet	SCD	26ae0d0a-34c0-4d16-951a-8d5a463c808b	26
198440	APAP 500 MG Oral Tablet	SY	26ae0d0a-34c0-4d16-951a-8d5a463c808b	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55301-175-03	55301017503	1 BOTTLE, PLASTIC in 1 CARTON (55301-175-03) > 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
55301-175-06	55301017506	2 in 1 CARTON					Historical
55301-175-12	55301017512	100 in 1 BOTTLE					Historical
55301-175-15	55301017515	1 BOTTLE, PLASTIC in 1 CARTON (55301-175-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
55301-175-60	55301017560	200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-175-60)	1993-04-02	0000-00-00	No	No	Current
55301-175-95	55301017595	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-175-95)	1993-04-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain Reliever	ARMY AND AIR FORCE EXCHANGE SERVICE \| LNK International, Inc.	2026-04-02	HUMAN OTC DRUG LABEL	26