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 36 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	43308b23-7d4f-4e4f-a497-af71920d86aa	2024-10-22	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e821c-9694-5db0-e053-2995a90ad034	2024-10-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e90e8-b9f1-1133-e053-2995a90a664b	2024-10-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	b96a2280-ec4f-7c61-e053-2995a90a18bb	2024-10-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	f17a18b0-a7c2-4c64-868c-460cf34e1f7d	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	0863aeaa-15ec-4c67-ba79-4dad54555bd2	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	American Health Packaging	3c0175a0-175b-48b8-9192-3f869690c0f2	2024-10-21	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	American Health Packaging	0d6553bd-3e18-4624-a83a-899bcafb3272	2024-10-21	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Childrens Acetaminophen Oral Suspension	ACETAMINOPHEN	American Health Packaging	8231dd91-e9e6-4350-a485-fa95d65a6d25	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	cf63c372-acdd-6e6e-e053-2995a90a1662	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	8b56bfc0-2253-458d-99a6-0b0f9ae0ba50	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	KROGER COMPANY	b9b63c38-83e7-62d2-e053-2a95a90a5526	2024-10-19	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	GoodSense	da4339c0-1822-41d8-8c20-214c379a5aa7	2024-10-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	AmeriSource Bergen	d571f520-a56e-4f7f-9214-d89197f742b6	2024-10-18	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health pain relief	ACETAMINOPHEN	Dolgencorp Inc	2e1470f5-e88f-4d1d-a308-170f7080387e	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	146c735b-5081-4de4-9025-d939d560bbba	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Regular Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	1462b308-a6a5-49ca-ab29-cacbf62caf0b	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Gelcaps Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	3588a3ef-a493-43ed-96e0-c259f0d087db	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	a2186895-944b-48cb-b3c2-eac208866c34	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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