Application 071010

Type: ANDA
Sponsor: ACINO PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	120MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071010-001	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL			1987-05-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`f41ea6bd6efb…`

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 31 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	a69fca9d-c0a0-4321-bf03-5c8e99cc07cc	2025-02-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	28e275fb-d615-4725-998c-946fe1bfdc0c	2025-01-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	38b839b6-de7d-4f33-a19a-efc92cdad92c	2025-01-24	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	523b68da-cd2a-4960-95e7-de5d51ce33c1	2025-01-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Little Remedies Childrens Fever Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	e1e44c85-d10c-4997-8f85-064cda7906eb	2025-01-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	Precision Dose Inc.	5cc698fa-0841-4851-ae21-0aac8b40eb0a	2025-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	RITE AID	d1f18c32-c043-7c97-e053-2a95a90a203e	2025-01-16	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Children Pain and Fever Reliever	ACETAMINOPHEN	Target Corporation	0dd643a4-3cbc-423d-95b4-ba373b09d895	2025-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	2651bf11-4d66-43ba-e054-00144ff88e88	2025-01-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	25626b46-78f8-7226-e054-00144ff8d46c	2025-01-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	a354b24e-0913-829f-e053-2995a90ad407	2025-01-11	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	8f221fdb-8138-c1a8-e053-2995a90a29c2	2025-01-11	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	32ea1230-f9ae-46b0-910e-05cd187cee34	2025-01-09	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	e817bc4a-43ef-4126-b903-aabd1390cd0c	2025-01-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	75d47849-a404-479b-a229-1b570d800114	2025-01-08	Warnings	Name fallback generic name: ACETAMINOPHEN
GeriCare Liquid Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceuticals, Corp	85a074da-14b7-4db5-9d47-8ad19f520721	2025-01-06	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen for children	ACETAMINOPHEN	A-S Medication Solutions	a9864f73-abb2-4cb1-a692-a48efdeeedf8	2025-01-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	6158e954-32d8-4718-e053-2a91aa0a27f3	2024-12-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	EXTRA STRENGTH PAIN RELIEF	NuCare Pharmaceuticals,Inc.	a32f346e-71d0-cc11-e053-2a95a90ae88c	2024-12-31	Warnings	Name fallback brand name: Acetaminophen
Pediacare Childrens Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	f9d531a2-234c-4feb-8f05-212dbee83dfe	2024-12-30	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.