fever reducing

Product NDC: 59779-579
Requested package NDC: 59779-579-53
11-digit product format: 597790579
Labeler code: 59779
Product ID: 59779-579_49e606bc-7b5f-4e1e-895c-fcfb92b46f8f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: CVS Pharmacy
Application: ANDA070607
Marketing category: ANDA
Marketing start: 2010-01-21
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 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
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 · 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	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`caaa826d4ba7…`
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…`

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: fever reducing
Brand name suffix: childrens
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
9d89544f-3a66-4f23-b609-381d027e0c95	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-579-53	fever reducingchildrens	12 in 1 CARTON	SUPPOSITORY	12		5
59779-579-53	fever reducingchildrens	1 in 1 BLISTER PACK	SUPPOSITORY	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-579-53	EA - Each	59779-579	1f8956f4-7524-4eb0-b4db-ee5d5b10691a	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]	3
COTTONSEED OIL	INACTIVE INGREDIENT	H3E878020N	FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-579	FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]	4	Current NDC, Legacy NDC, 2 package rows	20191121_9d89544f-3a66-4f23-b609-381d027e0c95.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 · 6 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 ndc (package): 59779-579-53 ndc (product): 59779-579 ndc11 (package): 59779057953
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	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	9d89544f-3a66-4f23-b609-381d027e0c95	5
198434	acetaminophen 120 MG Rectal Suppository	SCD	9d89544f-3a66-4f23-b609-381d027e0c95	5
198434	APAP 120 MG Rectal Suppository	SY	9d89544f-3a66-4f23-b609-381d027e0c95	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-579-53	59779057953	12 BLISTER PACK in 1 CARTON (59779-579-53) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2010-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Fever Reducing Suppositories Drug Facts	CVS Pharmacy	2025-06-06	HUMAN OTC DRUG LABEL	5