acetaminophen

Product NDC: 50090-0001
11-digit product format: 500900001
Labeler code: 50090
Product ID: 50090-0001_6e24b96f-e845-4f44-beaa-b43d15baf413
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: A-S Medication Solutions
Application: ANDA070607
Marketing category: ANDA
Marketing start: 2010-12-14
Marketing end: 2026-09-30
Substance: ACETAMINOPHEN
Active strength: 120 mg/1
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0001	50090-0001-0	D	Discontinued by firm		2026-08-03

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070607-001	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL			1987-04-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: acetaminophen
Brand name suffix: for children

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	120 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
198434	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
a9864f73-abb2-4cb1-a692-a48efdeeedf8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0001-0	acetaminophenfor children	12 in 1 CARTON	SUPPOSITORY	12		22
50090-0001-0	acetaminophenfor children	1 in 1 BLISTER PACK	SUPPOSITORY	1		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0001-0	EA - Each	50090-0001	27d54e6b-65ef-4831-ab57-820a219dcc4c	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]	1
COTTONSEED OIL	INACTIVE INGREDIENT	H3E878020N	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0001	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS]	22	Current NDC, Legacy NDC, 2 package rows	20250108_a9864f73-abb2-4cb1-a692-a48efdeeedf8.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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fever reducing childrens	ACETAMINOPHEN	CVS Pharmacy	9d89544f-3a66-4f23-b609-381d027e0c95	2025-06-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
Foster and Thrive Pain Reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	0a7d82f8-7615-4cef-b245-94b186f3c8fa	2025-04-07	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
acetaminophen for children	ACETAMINOPHEN	A-S Medication Solutions	a9864f73-abb2-4cb1-a692-a48efdeeedf8	2025-01-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 50090-0001
acetaminophen for children	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	62b3d354-d7f5-4ba0-b233-ea6be0d7ff03	2024-12-17	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	5f86e792-3262-4ee6-e053-2991aa0a54a0	2024-06-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceutiacals,Inc.	5d7ef1d2-d970-7b01-e053-2991aa0a1311	2024-06-04	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
pain reliever fever reducer childrens	ACETAMINOPHEN	Walgreen Company	f2085b26-5778-4656-8de3-9edd83f914dd	2023-05-03	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
acetaminophen for children	ACETAMINOPHEN	Proficient Rx LP	43fd900c-50c8-49c4-9f07-4fef924d533c	2022-09-01	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607

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
198434	acetaminophen 120 MG Rectal Suppository	PSN	a9864f73-abb2-4cb1-a692-a48efdeeedf8	22
198434	acetaminophen 120 MG Rectal Suppository	SCD	a9864f73-abb2-4cb1-a692-a48efdeeedf8	22
198434	APAP 120 MG Rectal Suppository	SY	a9864f73-abb2-4cb1-a692-a48efdeeedf8	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0001-0	50090000100	12 BLISTER PACK in 1 CARTON (50090-0001-0) > 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts	A-S Medication Solutions	2025-01-06	HUMAN OTC DRUG LABEL	22