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	2026-08-07
excluded package	package	55301-175	55301-175-06	D	Discontinued by firm	2026-08-07
excluded package	package	55301-175	55301-175-12	D	Discontinued by firm	2026-08-07

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…`

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 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable	ASPIRIN	Better Living Brands, LLC	7afce7b4-c86a-43f7-83cf-15ebffba2f35	2026-07-28	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	03b871e8-3e14-4ed8-a978-45129255b272	2026-07-27	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Rite Aid Corporation	17d27771-a112-474f-9a58-29af0d7e1af3	2026-07-27	Warnings	Exact identifier application number: M013
Children Pain Relief Gummy	ACETAMINOPHEN CHILDREN GUMMY	Gummy USA	5513db67-f023-7f47-e063-6294a90a2757	2026-07-24	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fdb7331a-d029-8b2a-e053-6294a90adfcd	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	5ada044e-50e8-4874-ac04-df5f1f9e735d	2026-07-24	Warnings	Exact identifier application number: M013
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	a63727c3-64d8-4ae9-8da3-974cae6beed2	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e4a2566e-48ec-4602-87e3-143398d15f33	2026-07-24	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Exact identifier application number: M013
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	ce58105b-f010-47af-8f31-6dd4ce4e9cba	2026-07-22	Warnings	Exact identifier application number: M013
Vicks PainQuil PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	0ad7b313-5d72-4cc0-97f0-1a30770350af	2026-07-22	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