foster and thrive pain reliever

Product NDC: 70677-1271
Requested package NDC: 70677-1271-1
11-digit product format: 706771271
Labeler code: 70677
Product ID: 70677-1271_c667c5ac-a898-49b0-834b-564d72fc7b9d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA070608
Marketing category: ANDA
Marketing start: 2025-04-15
Substance: ACETAMINOPHEN
Active strength: 650 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 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
A070608-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL			1986-12-01

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	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070608-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1986-12-01	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: foster and thrive pain reliever
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 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
198443	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
23780dab-91d8-434f-9342-f5f1ba0a3c0a	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
70677-1271-1	foster and thrive pain reliever	12 in 1 CARTON	SUPPOSITORY	12		2
70677-1271-1	foster and thrive pain reliever	1 in 1 BLISTER PACK	SUPPOSITORY	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1271-1	EA - Each	70677-1271	04e39da4-17d9-477b-8575-a2d160bf344a	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1271	FOSTER AND THRIVE PAIN RELIEVER (ACETAMINOPHEN) SUPPOSITORY [STRATEGIC SOURCING SERVICES LLC]	2	Current NDC, 2 package rows	20250418_23780dab-91d8-434f-9342-f5f1ba0a3c0a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	23780dab-91d8-434f-9342-f5f1ba0a3c0a	2025-04-15	Warnings	Exact identifier application applno (ANDA): 070608 application number: ANDA070608 ndc (package): 70677-1271-1 ndc (product): 70677-1271 ndc11 (package): 70677127101
acetaminophen pain reliever fever reducer	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	b43974c3-4db9-4201-beee-b22596a2b241	2025-02-12	Warnings	Exact identifier application applno (ANDA): 070608 application number: ANDA070608

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
198443	acetaminophen 650 MG Rectal Suppository	PSN	23780dab-91d8-434f-9342-f5f1ba0a3c0a	2
198443	acetaminophen 650 MG Rectal Suppository	SCD	23780dab-91d8-434f-9342-f5f1ba0a3c0a	2
198443	APAP 650 MG Rectal Suppository	SY	23780dab-91d8-434f-9342-f5f1ba0a3c0a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70677-1271-1	70677127101	12 BLISTER PACK in 1 CARTON (70677-1271-1) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2025-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mckesson Pain Reliever Drug Facts	Strategic Sourcing Services LLC	2025-04-15	HUMAN OTC DRUG LABEL	2