fever reducing

Product NDC
59779-579
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070607-001ACETAMINOPHENACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063f01610625f2…
2019-09-15 20:21 UTC2019-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06cb3db0bc1861…

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
IngredientStrength
ACETAMINOPHEN120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d89544f-3a66-4f23-b609-381d027e0c95Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-579-53fever reducingchildrens12 in 1 CARTONSUPPOSITORY125
59779-579-53fever reducingchildrens1 in 1 BLISTER PACKSUPPOSITORY15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-579-53EA - Each59779-5791f8956f4-7524-4eb0-b4db-ee5d5b10691a12019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]3
COTTONSEED OILINACTIVE INGREDIENTH3E878020NFEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-579FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20191121_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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fever reducing childrensACETAMINOPHENCVS Pharmacy9d89544f-3a66-4f23-b609-381d027e0c952025-06-06WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 59779-579
Foster and Thrive Pain RelieverACETAMINOPHENStrategic Sourcing Services LLC0a7d82f8-7615-4cef-b245-94b186f3c8fa2025-04-07WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENA-S Medication Solutionsa9864f73-abb2-4cb1-a692-a48efdeeedf82025-01-06WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENPadagis Israel Pharmaceuticals Ltd62b3d354-d7f5-4ba0-b233-ea6be0d7ff032024-12-17WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceuticals,Inc.5f86e792-3262-4ee6-e053-2991aa0a54a02024-06-06WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceutiacals,Inc.5d7ef1d2-d970-7b01-e053-2991aa0a13112024-06-04WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
pain reliever fever reducer childrensACETAMINOPHENWalgreen Companyf2085b26-5778-4656-8de3-9edd83f914dd2023-05-03WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENProficient Rx LP43fd900c-50c8-49c4-9f07-4fef924d533c2022-09-01WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198434acetaminophen 120 MG Rectal SuppositoryPSN9d89544f-3a66-4f23-b609-381d027e0c955
198434acetaminophen 120 MG Rectal SuppositorySCD9d89544f-3a66-4f23-b609-381d027e0c955
198434APAP 120 MG Rectal SuppositorySY9d89544f-3a66-4f23-b609-381d027e0c955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-579-535977905795312 BLISTER PACK in 1 CARTON (59779-579-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2010-01-210000-00-00NoNoCurrent