FDA.reportPublic FDA data

Naftifine Hydrochloride

Product NDC
51672-1362
Requested package NDC
51672-1362-1
11-digit product format
516721362
Labeler code
51672
Product ID
51672-1362_39620da3-e660-e94f-e063-6294a90afd69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naftifine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205975
Marketing category
ANDA
Marketing start
2016-09-08
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [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
A205975-001NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08

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 UTC2026-02A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205975-001NAFTIFINE HYDROCHLORIDE1%CREAM / TOPICALRS2016-09-08cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFTIFINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25UR9N9041Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d50961c2-e97f-4583-91d6-7cafd25a8c3dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f630d5a-8a28-4ac5-8ede-8b54b7617055Product name320210512
6aca302d-6492-4ac9-8829-e023cb64c91cProduct name120190627
ba2e3195-29b1-b94a-4345-149632e97b51Product name320161117
7ac69d99-c06d-0e83-7872-6229bc9878f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1362-1Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-1Naftifine Hydrochloride15 g in 1 TUBECREAM153
51672-1362-2Naftifine Hydrochloride30 g in 1 TUBECREAM303
51672-1362-2Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-3Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-3Naftifine Hydrochloride60 g in 1 TUBECREAM603
51672-1362-8Naftifine Hydrochloride90 g in 1 TUBECREAM903
51672-1362-8Naftifine Hydrochloride1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1362-3GM - Gram51672-136236a9aab6-5a08-449f-9e00-1c6868eb25d512017-03-06
51672-1362-8GM - Gram51672-13629d8249c0-21a8-45d3-9e5b-b13785221f7012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1362NAFTIFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 8 package rows20180621_d50961c2-e97f-4583-91d6-7cafd25a8c3d.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
Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d50961c2-e97f-4583-91d6-7cafd25a8c3d2025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205975
application number: ANDA205975
ndc (package): 51672-1362-1
ndc (product): 51672-1362
ndc11 (package): 51672136201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896110naftifine HCl 1 % Topical CreamPSNd50961c2-e97f-4583-91d6-7cafd25a8c3d3
896110naftifine hydrochloride 10 MG/ML Topical CreamSCDd50961c2-e97f-4583-91d6-7cafd25a8c3d3
896110naftifine hydrochloride 1 % Topical CreamSYd50961c2-e97f-4583-91d6-7cafd25a8c3d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1362-1516721362011 TUBE in 1 CARTON (51672-1362-1) / 15 g in 1 TUBE1 tube2016-09-080000-00-00NoNoCurrent