Atralin

Product NDC
13548-070
11-digit product format
135480070
Labeler code
13548
Product ID
13548-070_77e095d6-f941-44ef-ad04-08d607843d65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA022070
Marketing category
NDA
Marketing start
2007-07-26
Substance
TRETINOIN
Active strength
.05 g/100g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13548-07013548-070-01DDiscontinued by firm2026-08-07

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022070-001ATRALINTRETINOIN0.05%GEL / TOPICALABRLD, RS2007-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022070-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022070-001ATRALIN0.05%GEL / TOPICALABRLD, RS2007-07-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022070-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022070-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022070-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022070-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022070-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022070-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022070-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022070-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022070-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022070-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022070-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022070-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022070-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022070-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022070-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022070-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022070-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022070-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022070-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022070-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022070-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022070-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022070-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022070-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022070-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022070-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022070-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022070-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022070-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022070-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022070-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022070-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022070-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022070-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022070-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022070-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022070-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022070-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022070-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022070-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Atralin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.05 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245723Internal RxNorm lookup
749329Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6b45969-a64a-4ce3-b3b6-157d2568a301Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13548-070-01Atralin2 g in 1 TUBEGEL210
13548-070-45Atralin1 in 1 PACKAGEGEL110
13548-070-45Atralin45 g in 1 TUBEGEL4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13548-070-45GM - Gram13548-070872ee8a3-2ea2-4151-af0e-525a0579988312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
TretinoinACTIVE MOIETY5688UTC01RATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
butylparabenINACTIVE INGREDIENT3QPI1U3FV8ATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
ethylparabenINACTIVE INGREDIENT14255EXE39ATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
glycerinINACTIVE INGREDIENTPDC6A3C0OXATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
methylparabenINACTIVE INGREDIENTA2I8C7HI9TATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
octoxynol-9INACTIVE INGREDIENT7JPC6Y25QSATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
trolamineINACTIVE INGREDIENT9O3K93S3TKATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5
waterINACTIVE INGREDIENT059QF0KO0RATRALIN (TRETINOIN) GEL [CORIA LABORATORIES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13548-070ATRALIN (TRETINOIN) GEL [BAUSCH HEALTH US, LLC]9Current NDC, Legacy NDC, 3 package rows20240423_b6b45969-a64a-4ce3-b3b6-157d2568a301.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TretinoinTRETINOINOceanside Pharmaceuticalsfebda58b-c9ee-4b95-bee7-dca5f2645f982024-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022070
application number: NDA022070
AtralinTRETINOINBausch Health US, LLCb6b45969-a64a-4ce3-b3b6-157d2568a3012024-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022070
application number: NDA022070
ndc (product): 13548-070
TretinoinTRETINOINObagi Cosmeceuticals LLCc5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b2021-05-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022070
application number: NDA022070

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749329Atralin 0.05 % Topical GelPSNb6b45969-a64a-4ce3-b3b6-157d2568a30110
245723tretinoin 0.05 % Topical GelPSNb6b45969-a64a-4ce3-b3b6-157d2568a30110
749329tretinoin 0.0005 MG/MG Topical Gel [Atralin]SBDb6b45969-a64a-4ce3-b3b6-157d2568a30110
245723tretinoin 0.0005 MG/MG Topical GelSCDb6b45969-a64a-4ce3-b3b6-157d2568a30110
749329Atralin 0.0005 MG/MG Topical GelSYb6b45969-a64a-4ce3-b3b6-157d2568a30110
749329Atralin 0.05 % Topical GelSYb6b45969-a64a-4ce3-b3b6-157d2568a30110
245723tretinoin 0.05 % Topical GelSYb6b45969-a64a-4ce3-b3b6-157d2568a30110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13548-070-01135480070012 g in 1 TUBE2 gHistorical
13548-070-45135480070451 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE1 tube2007-07-260000-00-00NoNoCurrent