Home NDC 21130-283 Signature Care Ibuprofen PM
Product NDC 21130-283
11-digit product format 211300283
Labeler code 21130
Product ID 21130-283_1dbef407-03fb-444d-b78e-781b60d1082a
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine citrate, ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Safeway
Application ANDA079113
Marketing category ANDA
Marketing start 2015-09-01
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength 38 mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21130-283 21130-283-58 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21130-283 21130-283-27 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21130-283 21130-283-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21130-283-27 Signature Care Ibuprofen PM 80 in 1 BOTTLE TABLET, FILM COATED 80 6 21130-283-27 Signature Care Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 6 21130-283-58 Signature Care Ibuprofen PM 40 in 1 BOTTLE TABLET, FILM COATED 40 6 21130-283-58 Signature Care Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 6 21130-283-60 Signature Care Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 6 21130-283-60 Signature Care Ibuprofen PM 20 in 1 BOTTLE TABLET, FILM COATED 20 6 21130-283-76 Signature Care Ibuprofen PM 1 in 1 CARTON TABLET, FILM COATED 1 6 21130-283-76 Signature Care Ibuprofen PM 120 in 1 BOTTLE TABLET, FILM COATED 120 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE CITRATE ACTIVE INGREDIENT 4OD433S209 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-283 SIGNATURE CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [SAFEWAY] 6 Legacy NDC, 8 package rows 20250223_790182a2-479f-46bc-9432-acee4362fb70.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 21130-283-27 21130028327 1 BOTTLE in 1 CARTON (21130-283-27) > 80 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-04 0000-00-00 No No Current 21130-283-58 21130028358 1 BOTTLE in 1 CARTON (21130-283-58) > 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-04 0000-00-00 No No Current 21130-283-60 21130028360 1 BOTTLE in 1 CARTON (21130-283-60) > 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-01 0000-00-00 No No Current 21130-283-76 21130028376 1 BOTTLE in 1 CARTON (21130-283-76) > 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-03-28 0000-00-00 No No Current