Home NDC 65692-0412 IBUPROFEN
Product NDC 65692-0412
11-digit product format 656920412
Labeler code 65692
Product ID 65692-0412_204d2366-e1a1-4794-96ec-664e8224c416
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Raining Rose Inc.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-08-01
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65692-0412-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65692-0412-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65692-0412-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65692-0412-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65692-0412-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65692-0412-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65692-0412-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65692-0412-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65692-0412-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65692-0412-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65692-0412-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65692-0412-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 65692-0412-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 65692-0412-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65692-0412-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 65692-0412-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 65692-0412-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 65692-0412-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 65692-0412-1 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65692-0412-1 IBUPROFEN 12 in 1 VIAL TABLET, FILM COATED 12 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65692-0412 IBUPROFEN TABLET, FILM COATED [RAINING ROSE INC.] 4 Legacy NDC, 1 package rows 20191106_2f36fa80-7838-4b2b-ab89-1113b087cde4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 65692-0412-1 65692041201 12 in 1 VIAL Historical