acetaminophen

Product NDC: 63187-373
11-digit product format: 631870373
Labeler code: 63187
Product ID: 63187-373_a4458cf8-9a74-4beb-858c-611588e6b6b0
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Proficient Rx LP
Application: ANDA070607
Marketing category: ANDA
Marketing start: 2010-12-14
Substance: ACETAMINOPHEN
Active strength: 120 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
Listing expiration: 2026-12-31

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
43fd900c-50c8-49c4-9f07-4fef924d533c	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	Strength	SPL version
63187-373-12	acetaminophenfor children	1 in 1 BLISTER PACK	SUPPOSITORY	1		5
63187-373-12	acetaminophenfor children	12 in 1 CARTON	SUPPOSITORY	12		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-373-12	EA - Each	63187-373	bd529284-a6e0-42cd-aa81-fbd10fd2ee86	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-373	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 2 package rows	20220911_43fd900c-50c8-49c4-9f07-4fef924d533c.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
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 ndc (product): 63187-373

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	43fd900c-50c8-49c4-9f07-4fef924d533c	5
198434	acetaminophen 120 MG Rectal Suppository	SCD	43fd900c-50c8-49c4-9f07-4fef924d533c	5
198434	APAP 120 MG Rectal Suppository	SY	43fd900c-50c8-49c4-9f07-4fef924d533c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-373-12	63187037312	12 BLISTER PACK in 1 CARTON (63187-373-12) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2016-09-01	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	Proficient Rx LP	2022-09-01	HUMAN OTC DRUG LABEL	5