Home NDC 68791-101-01 Derma-Smoothe/FS
Product NDC 68791-101
Requested package NDC 68791-101-01
11-digit product format 687910101
Labeler code 68791
Product ID 68791-101_a1decdf5-a06c-40b9-a2b4-d27006b8f01c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form OIL
Route TOPICAL
Labeler Royal Pharmaceuticals
Application NDA019452
Marketing category NDA
Marketing start 1995-02-16
Substance FLUOCINOLONE ACETONIDE
Active strength .11 mg/mL
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019452-001 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 N019452-002 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 N019452-003 DERMOTIC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Derma-Smoothe/FS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .11 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0CD5FD6S2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191307 Internal RxNorm lookup 1191309 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 68791-101-01 Derma-Smoothe/FS 1 in 1 CARTON OIL 1 13 68791-101-01 Derma-Smoothe/FS 20 mL in 1 BOTTLE OIL 20 13 68791-101-04 Derma-Smoothe/FS 118.28 mL in 1 BOTTLE OIL 118.28 13 68791-101-04 Derma-Smoothe/FS 1 in 1 CARTON OIL 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68791-101 DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS] 12 Current NDC, Legacy NDC, 4 package rows 20250426_bc61c619-a71c-46f5-80f1-9e9ee71134aa.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68791-101-01 68791010101 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE 1 bottle 2024-05-06 Yes No Historical