Home NDC 0299-3848-04 Clobex
Product NDC 0299-3848
Requested package NDC 0299-3848-04
11-digit product format 002993848
Labeler code 0299
Product ID 0299-3848_a9ce2f1a-7cba-4759-ac1d-7638cf99c7be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form LOTION
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA021535
Marketing category NDA
Marketing start 2003-08-01
Substance CLOBETASOL PROPIONATE
Active strength .05 g/100mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 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 N021535-001 CLOBEX CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021535-001 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 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021535-001 CLOBEX 0.05% LOTION / TOPICAL AB RLD, RS 2003-07-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clobetasol Propionate ACTIVE INGREDIENT 779619577M CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 Clobetasol ACTIVE MOIETY ADN79D536H CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 CARBOMER 1342 INACTIVE INGREDIENT 809Y72KV36 CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 PEG-6 ISOSTEARATE INACTIVE INGREDIENT 0E2639OTJY CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 Water INACTIVE INGREDIENT 059QF0KO0R CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 13 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER 1342 INACTIVE INGREDIENT 809Y72KV36 CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3848 CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.] 14 Current NDC, Legacy NDC, 4 package rows 20180212_54eca64c-af43-48ba-bf86-bab9d8e46bb6.zip
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 0299-3848-04 00299384804 1 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE 1 bottle 2003-08-01 0000-00-00 No No Current