Home NDC 41520-050 Care One Ibuprofen PM
Product NDC 41520-050
11-digit product format 415200050
Labeler code 41520
Product ID 41520-050_af71245d-9e26-4aaf-b061-3b2dc519572c
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine citrate and ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Sales Company
Application ANDA079113
Marketing category ANDA
Marketing start 2009-02-20
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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Care One Ibuprofen PM
Listing expiration 2027-12-31 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 41520-050-27 Care One Ibuprofen PM 80 in 1 BOTTLE TABLET, FILM COATED 80 11 41520-050-27 Care One Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 11 41520-050-48 Care One Ibuprofen PM 180 in 1 BOTTLE TABLET, FILM COATED 180 11 41520-050-48 Care One Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 11 41520-050-58 Care One Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 11 41520-050-58 Care One Ibuprofen PM 40 in 1 BOTTLE TABLET, FILM COATED 40 11 41520-050-60 Care One Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 11 41520-050-60 Care One Ibuprofen PM 20 in 1 BOTTLE TABLET, FILM COATED 20 11 41520-050-76 Care One Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 11 41520-050-76 Care One Ibuprofen PM 120 in 1 BOTTLE TABLET, FILM COATED 120 11 41520-050-82 Care One Ibuprofen PM 200 in 1 BOTTLE TABLET, FILM COATED 200 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE CITRATE ACTIVE INGREDIENT 4OD433S209 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 IBUPROFEN ACTIVE MOIETY WK2XYI10QM CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-050 CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY] 10 Current NDC, Legacy NDC, 11 package rows 20250423_d5bf76d1-6fed-4f6b-8507-3e8973295d67.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 · 22 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 41520-050-27 41520005027 1 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-20 0000-00-00 No No Current 41520-050-48 41520005048 1 BOTTLE in 1 CARTON (41520-050-48) > 180 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-03-06 0000-00-00 No No Current 41520-050-58 41520005058 1 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-20 0000-00-00 No No Current 41520-050-60 41520005060 1 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2009-02-20 0000-00-00 No No Current 41520-050-76 41520005076 1 in 1 CARTON Historical 41520-050-82 41520005082 200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82) 2017-09-05 0000-00-00 No No Current