Home NDC 0299-3847 Clobex
Product NDC 0299-3847
11-digit product format 002993847
Labeler code 0299
Product ID 0299-3847_026c970e-0817-4192-8c3d-0c9693ef3e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form SHAMPOO
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA021644
Marketing category NDA
Marketing start 2004-03-01
Marketing end 2027-01-01
Substance CLOBETASOL PROPIONATE
Active strength .05 g/100mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
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 · 1 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 0299-3847 0299-3847-00 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021644-001 CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021644-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0299-3847-00 Clobex 1 in 1 BLISTER PACK SHAMPOO 1 17 0299-3847-04 Clobex 118 mL in 1 BOTTLE SHAMPOO 118 17 0299-3847-04 Clobex 1 in 1 CARTON SHAMPOO 1 17 0299-3847-05 Clobex 15 mL in 1 BOTTLE SHAMPOO 15 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clobetasol propionate ACTIVE INGREDIENT 779619577M CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 Clobetasol ACTIVE MOIETY ADN79D536H CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 alcohol INACTIVE INGREDIENT 3K9958V90M CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 COCO-BETAINE INACTIVE INGREDIENT 03DH2IZ3FY CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 POLYQUATERNIUM-10 (400 CPS AT 2%) INACTIVE INGREDIENT HB1401PQFS CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12 water INACTIVE INGREDIENT 059QF0KO0R CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3847 CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.] 16 Current NDC, Legacy NDC, 4 package rows 20241027_acb3a25e-5746-4df6-89fd-cf3023e755cc.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 · 1 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 0299-3847-00 00299384700 1 BOTTLE in 1 BLISTER PACK (0299-3847-00) > 15 mL in 1 BOTTLE (0299-3847-05) 1 bottle 2004-03-01 0000-00-00 No No Current 0299-3847-04 00299384704 1 BOTTLE in 1 CARTON (0299-3847-04) / 118 mL in 1 BOTTLE 1 bottle 2004-03-01 2027-01-01 No No Current 0299-3847-05 00299384705 15 mL in 1 BOTTLE 15 ml Historical