FDA.reportPublic FDA data

Clindamycin Phosphate and Tretinoin

Product NDC
73473-306
11-digit product format
734730306
Labeler code
73473
Product ID
73473-306_b52c449c-1499-46c3-a10a-3e803c307af2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate and tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Solaris Pharma Corporation
Application
ANDA212845
Marketing category
ANDA
Marketing start
2025-01-03
Substance
CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength
10; .25 mg/g; mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOINCLINDAMYCIN PHOSPHATE; TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212845-001AB2

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-104b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212845-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB22022-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212845-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212845-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212845-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212845-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212845-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212845-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212845-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212845-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212845-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212845-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212845-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212845-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212845-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212845-001AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212845-001AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212845-001AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212845-001AB214b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212845-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212845-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212845-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212845-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212845-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212845-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212845-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A212845-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A212845-001AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212845-001AB213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212845-001AB21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212845-001AB21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212845-001AB21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212845-001AB21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212845-001CGT2022-10-095c6f7cd8ea54…
2023-01-26 05:58 UTC2023-01A212845-001CGT2022-10-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212845-001CGT2022-10-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212845-001CGT2022-10-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212845-001CGT2022-10-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212845-001CGT2022-10-09cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate and Tretinoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/g
TRETINOIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
882548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3ad6c2d-d106-464d-8e27-67ae94793e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
73473-306-302023-08-14These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL. CLINDAMYCIN PHOSPAHTE AND TRETINOIN gel, for topical use only Initial U.S. Approval: 2006
73473-306-602023-08-14These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL. CLINDAMYCIN PHOSPAHTE AND TRETINOIN gel, for topical use only Initial U.S. Approval: 2006
73473-306-302023-07-28These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL. CLINDAMYCIN PHOSPAHTE AND TRETINOIN gel, for topical use only Initial U.S. Approval: 2006
73473-306-602023-07-28These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL. CLINDAMYCIN PHOSPAHTE AND TRETINOIN gel, for topical use only Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-306-30Clindamycin Phosphate and Tretinoin1 in 1 CARTONGEL16
73473-306-30Clindamycin Phosphate and Tretinoin30 g in 1 TUBEGEL306
73473-306-60Clindamycin Phosphate and Tretinoin1 in 1 CARTONGEL16
73473-306-60Clindamycin Phosphate and Tretinoin60 g in 1 TUBEGEL606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-306-30GM - Gram73473-306772b9de7-2aa0-432f-8454-9dfdc52573b112022-05-04
73473-306-60GM - Gram73473-30634c845d5-1123-4053-a645-d3ad69602ead12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-306CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL [SOLARIS PHARMA CORPORATION]6Current NDC, Legacy NDC, 4 package rows20250104_c3ad6c2d-d106-464d-8e27-67ae94793e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and TretinoinCLINDAMYCIN PHOSPHATE AND TRETINOINSolaris Pharma Corporationc3ad6c2d-d106-464d-8e27-67ae94793e882025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212845
application number: ANDA212845
ndc (product): 73473-306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882548clindamycin phosphate 1.2 % / tretinoin 0.025 % Topical GelPSNc3ad6c2d-d106-464d-8e27-67ae94793e886
882548clindamycin phosphate 0.012 MG/MG / tretinoin 0.00025 MG/MG Topical GelSCDc3ad6c2d-d106-464d-8e27-67ae94793e886
882548clindamycin phosphate 1.2 % (clindamycin 1 % ) / tretinoin 0.025 % Topical GelSYc3ad6c2d-d106-464d-8e27-67ae94793e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73473-306-30734730306301 TUBE in 1 CARTON (73473-306-30) / 30 g in 1 TUBE1 tube2025-01-030000-00-00NoNoCurrent
73473-306-60734730306601 TUBE in 1 CARTON (73473-306-60) / 60 g in 1 TUBE1 tube2025-01-030000-00-00NoNoCurrent