Tretinoin Gel Microsphere

Product NDC
66530-260
11-digit product format
665300260
Labeler code
66530
Product ID
66530-260_0fd10595-1ff5-450c-8d0f-8d46b54959f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Spear Dermatology Products Inc
Application
NDA020475
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-10-01
Marketing end
2019-11-30
Substance
TRETINOIN
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66530-260DDiscontinued by firm2026-08-03
excluded packagepackage66530-26066530-260-20DDiscontinued by firm2026-08-03
excluded packagepackage66530-26066530-260-45DDiscontinued by firm2026-08-03
excluded packagepackage66530-26066530-260-50DDiscontinued by firm2026-08-03

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66530-260-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66530-260-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66530-260-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66530-260-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66530-260-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66530-260-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66530-260-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66530-260-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66530-260-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66530-260-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66530-260-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66530-260-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66530-260-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66530-260-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66530-260-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66530-260-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66530-260-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66530-260-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66530-260-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66530-260-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66530-260-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66530-260-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66530-260-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66530-260-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66530-260-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66530-260-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66530-260-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66530-260-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66530-260-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66530-260-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66530-260-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66530-260-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66530-260-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66530-260-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66530-260-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66530-260-20557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020475-001RETIN-A MICROTRETINOIN0.1%GEL / TOPICALRLD, RS1997-02-07
N020475-002RETIN-A MICROTRETINOIN0.04%GEL / TOPICALRLD, RS2002-05-10
N020475-003RETIN-A-MICROTRETINOIN0.08%GEL / TOPICALABRLD, RS2014-01-28
N020475-004RETIN-A-MICROTRETINOIN0.06%GEL / TOPICALABRLD, RS2017-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020475-003AB
N020475-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020475-001RETIN-A MICRO0.1%GEL / TOPICALRLD, RS1997-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N020475-002RETIN-A MICRO0.04%GEL / TOPICALRLD, RS2002-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N020475-003RETIN-A-MICRO0.08%GEL / TOPICALABRLD, RS2014-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020475-004RETIN-A-MICRO0.06%GEL / TOPICALRLD, RS2017-10-23d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020475-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020475-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020475-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020475-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020475-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020475-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020475-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020475-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020475-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020475-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020475-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020475-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020475-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020475-003AB18072bd15b7f6…
2019-12-13 00:20 UTC2019-12N020475-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020475-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020475-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020475-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020475-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020475-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020475-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020475-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020475-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020475-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020475-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020475-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020475-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020475-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020475-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020475-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020475-003AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020475-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020475-004AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66530-260-20GM - Gram66530-260cd83f0fb-9558-4ab5-bed3-2be36548c4de12014-11-05
66530-260-45GM - Gram66530-2602c64b524-34f5-4def-aa84-621df197f7b012014-11-05
66530-260-50GM - Gram66530-2600b2f961d-0670-4bef-b2d6-9d9c869aad0a12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
TretinoinACTIVE MOIETY5688UTC01RTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Carbomer Homopolymer Type BINACTIVE INGREDIENTHHT01ZNK31TRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31TRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
Sorbic AcidINACTIVE INGREDIENTX045WJ989BTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1
WaterINACTIVE INGREDIENT059QF0KO0RTRETINOIN GEL MICROSPHERE (TRETINOIN) GEL [SPEAR DERMATOLOGY PRODUCTS INC]1

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TretinoinTRETINOINOceanside Pharmaceuticalsd3c528d2-429d-4f37-9ebf-eee8b9fd30502025-09-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020475
application number: NDA020475
Retin-A MICROTRETINOINBausch Health US LLC08ab7e0c-1437-455f-815c-98904d96a2892025-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020475
application number: NDA020475