Home NDC 55045-3691 Tretinoin
Product NDC 55045-3691
11-digit product format 550453691
Labeler code 55045
Product ID 55045-3691_733ba226-4bba-4b0d-9bba-ec404e3c5977
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Dispensing Solutions, Inc.
Application ANDA075213
Marketing category ANDA
Marketing start 1998-12-24
Marketing end 0000-00-00
Substance TRETINOIN
Active strength 1 mg/g
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 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 55045-3691-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 55045-3691-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 55045-3691-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55045-3691-1 110d247fa046…a55b01930146…
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 A075213-001 TRETINOIN TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075213-001 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 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 55045-3691-1 Tretinoin 20 g in 1 TUBE CREAM 20 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 TRETINOIN ACTIVE MOIETY 5688UTC01R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55045-3691 TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20130719_ababee41-4f21-44d4-b139-02735fd950ee.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55045-3691-1 55045369101 20 g in 1 TUBE 20 g Historical