FDA.reportPublic FDA data

acetaminophen

Product NDC
45802-730
11-digit product format
458020730
Labeler code
45802
Product ID
45802-730_4926c350-ee6f-446c-a63d-cc7170f9a68c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA070608
Marketing category
ANDA
Marketing start
2010-10-28
Marketing end
2026-11-30
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070608-001ACETAMINOPHENACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0184e616aacf4f…
2026-08-18 06:07:402026-07A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-013f01610625f2…
2019-09-15 20:21 UTC2019-09A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070608-001ACETAMINOPHEN650MGSUPPOSITORY / RECTAL1986-12-01f41ea6bd6efb…

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
acetaminophen
Brand name suffix
pain reliever fever reducer

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 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
198443Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b43974c3-4db9-4201-beee-b22596a2b241Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-730-00acetaminophenpain reliever fever reducer1 in 1 BLISTER PACKSUPPOSITORY17
45802-730-30acetaminophenpain reliever fever reducer12 in 1 CARTONSUPPOSITORY127
45802-730-30acetaminophenpain reliever fever reducer1 in 1 BLISTER PACKSUPPOSITORY17
45802-730-32acetaminophenpain reliever fever reducer50 in 1 CARTONSUPPOSITORY507
45802-730-32acetaminophenpain reliever fever reducer1 in 1 BLISTER PACKSUPPOSITORY17
45802-730-33acetaminophenpain reliever fever reducer1 in 1 BLISTER PACKSUPPOSITORY17
45802-730-33acetaminophenpain reliever fever reducer100 in 1 CARTONSUPPOSITORY1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-730-00EA - Each45802-7303c5924a3-7481-46b6-b02f-32490b82f24412017-09-11
45802-730-30EA - Each45802-7304eb304ff-ffb0-4674-89aa-a85f2788129412012-07-24
45802-730-32EA - Each45802-730981014ad-d51a-48bd-a0aa-70d4209cf28412012-07-24
45802-730-33EA - Each45802-730d672d7a1-16aa-4aea-aa1d-91d28743bda712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
COTTONSEED OILINACTIVE INGREDIENTH3E878020NACETAMINOPHEN PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PERRIGO NEW YORK INC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-730ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 7 package rows20250214_b43974c3-4db9-4201-beee-b22596a2b241.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC23780dab-91d8-434f-9342-f5f1ba0a3c0a2025-04-15WarningsExact identifier
application applno (ANDA): 070608
application number: ANDA070608
acetaminophen pain reliever fever reducerACETAMINOPHENPadagis Israel Pharmaceuticals Ltdb43974c3-4db9-4201-beee-b22596a2b2412025-02-12WarningsExact identifier
application applno (ANDA): 070608
application number: ANDA070608
ndc (product): 45802-730

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198443acetaminophen 650 MG Rectal SuppositoryPSNb43974c3-4db9-4201-beee-b22596a2b2417
198443acetaminophen 650 MG Rectal SuppositorySCDb43974c3-4db9-4201-beee-b22596a2b2417
198443APAP 650 MG Rectal SuppositorySYb43974c3-4db9-4201-beee-b22596a2b2417
198443acetaminophen 650 MG Rectal SuppositoryPSNcddc841a-ab37-4480-a9d1-4764cba3ec801
198443acetaminophen 650 MG Rectal SuppositorySCDcddc841a-ab37-4480-a9d1-4764cba3ec801
198443APAP 650 MG Rectal SuppositorySYcddc841a-ab37-4480-a9d1-4764cba3ec801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-730-00458020730001 SUPPOSITORY in 1 BLISTER PACK (45802-730-00) 1 suppository2010-10-282026-11-30NoNoCurrent
45802-730-304580207303012 BLISTER PACK in 1 CARTON (45802-730-30) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2010-10-282026-11-30NoNoCurrent
45802-730-324580207303250 BLISTER PACK in 1 CARTON (45802-730-32) / 1 SUPPOSITORY in 1 BLISTER PACK50 blister pack2010-11-222026-11-30NoNoCurrent
45802-730-3345802073033100 BLISTER PACK in 1 CARTON (45802-730-33) / 1 SUPPOSITORY in 1 BLISTER PACK100 blister pack2010-10-282026-11-30NoNoCurrent