Home NDC 36800-050 Topcare Ibuprofen PM
Product NDC 36800-050
11-digit product format 368000050
Labeler code 36800
Product ID 36800-050_ce7b2954-4165-4ca8-902d-8349eea450be
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine citrate and ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application ANDA079113
Marketing category ANDA
Marketing start 2009-02-18
Substance DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength 38; 200 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
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 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET / ORAL 2008-12-22
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079113-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE 38MG;200MG TABLET / ORAL 2008-12-22 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 Topcare Ibuprofen PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE CITRATE 38 mg/1 IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4OD433S209 Internal UNII lookup WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 895664 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-050-27 Topcare Ibuprofen PM 80 in 1 BOTTLE TABLET, FILM COATED 80 8 36800-050-27 Topcare Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 8 36800-050-58 Topcare Ibuprofen PM 40 in 1 BOTTLE TABLET, FILM COATED 40 8 36800-050-58 Topcare Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 8 36800-050-60 Topcare Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 8 36800-050-60 Topcare Ibuprofen PM 20 in 1 BOTTLE TABLET, FILM COATED 20 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE CITRATE ACTIVE INGREDIENT 4OD433S209 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-050 TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 8 Current NDC, Legacy NDC, 6 package rows 20250423_1435e627-144e-4dc8-9ad6-58d91cbd9094.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-050-27 36800005027 1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-24 0000-00-00 No No Current 36800-050-58 36800005058 1 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-18 0000-00-00 No No Current 36800-050-60 36800005060 1 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-19 0000-00-00 No No Current