FDA.reportPublic FDA data

acetaminophen

Product NDC
45802-732
11-digit product format
458020732
Labeler code
45802
Product ID
45802-732_804d45c6-9798-4374-896a-a1f15e40077a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA070607
Marketing category
ANDA
Marketing start
2010-12-14
Marketing end
2026-09-30
Substance
ACETAMINOPHEN
Active strength
120 mg/1
NDC exclude flag
No
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
acetaminophen
Brand name suffix
for children

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
62b3d354-d7f5-4ba0-b233-ea6be0d7ff03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-732-30acetaminophenfor children12 in 1 CARTONSUPPOSITORY126
45802-732-30acetaminophenfor children1 in 1 BLISTER PACKSUPPOSITORY16
45802-732-33acetaminophenfor children100 in 1 CARTONSUPPOSITORY1006
45802-732-33acetaminophenfor children1 in 1 BLISTER PACKSUPPOSITORY16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-732-30EA - Each45802-732e8e1375a-1e68-4050-a5fe-ab9af8d2304e12012-07-24
45802-732-33EA - Each45802-7322042f506-8d51-4446-8d6e-4ea04cd9699012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
COTTONSEED OILINACTIVE INGREDIENTH3E878020NACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-732ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 4 package rows20241219_62b3d354-d7f5-4ba0-b233-ea6be0d7ff03.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
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
ndc (product): 45802-732
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 SuppositoryPSNa9864f73-abb2-4cb1-a692-a48efdeeedf822
198434acetaminophen 120 MG Rectal SuppositorySCDa9864f73-abb2-4cb1-a692-a48efdeeedf822
198434APAP 120 MG Rectal SuppositorySYa9864f73-abb2-4cb1-a692-a48efdeeedf822
198434acetaminophen 120 MG Rectal SuppositoryPSN5d7ef1d2-d970-7b01-e053-2991aa0a13116
198434acetaminophen 120 MG Rectal SuppositoryPSN62b3d354-d7f5-4ba0-b233-ea6be0d7ff036
198434acetaminophen 120 MG Rectal SuppositorySCD5d7ef1d2-d970-7b01-e053-2991aa0a13116
198434acetaminophen 120 MG Rectal SuppositorySCD62b3d354-d7f5-4ba0-b233-ea6be0d7ff036
198434APAP 120 MG Rectal SuppositorySY5d7ef1d2-d970-7b01-e053-2991aa0a13116
198434APAP 120 MG Rectal SuppositorySY62b3d354-d7f5-4ba0-b233-ea6be0d7ff036
198434acetaminophen 120 MG Rectal SuppositoryPSN43fd900c-50c8-49c4-9f07-4fef924d533c5
198434acetaminophen 120 MG Rectal SuppositoryPSN5f86e792-3262-4ee6-e053-2991aa0a54a05
198434acetaminophen 120 MG Rectal SuppositorySCD43fd900c-50c8-49c4-9f07-4fef924d533c5
198434acetaminophen 120 MG Rectal SuppositorySCD5f86e792-3262-4ee6-e053-2991aa0a54a05
198434APAP 120 MG Rectal SuppositorySY43fd900c-50c8-49c4-9f07-4fef924d533c5
198434APAP 120 MG Rectal SuppositorySY5f86e792-3262-4ee6-e053-2991aa0a54a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-732-304580207323012 BLISTER PACK in 1 CARTON (45802-732-30) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2011-03-092026-09-30NoNoCurrent
45802-732-3345802073233100 BLISTER PACK in 1 CARTON (45802-732-33) / 1 SUPPOSITORY in 1 BLISTER PACK100 blister pack2010-12-142026-09-30NoNoCurrent