FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
73469-7215
Requested package NDC
73469-7215-2
11-digit product format
734697215
Labeler code
73469
Product ID
73469-7215_4e91f275-e628-27c4-e063-6294a90ad0c4
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Scholl's Wellness Company LLC
Application
ANDA077511
Marketing category
ANDA
Marketing start
2025-09-11
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A077511-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02

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
2026-08-01 22:54:322026-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (package): 73469-7215-2
ndc (product): 73469-7215
ndc11 (package): 73469721502
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc6016e546-6c02-4af0-888c-c0899865c5f02025-09-30WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
equate Athletes FootTERBINAFINE HYDROCHLORIDEWal-Mart Stores Ince799c808-7c0f-482d-99d2-35fc34dbb2ea2025-08-14WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEAmerisourceBergen93ea9e7f-6914-4df2-8ca0-27c4538066232025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDERite Aid Corporationa7b0a70b-a117-48cf-a6bc-260be1dac1e72025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC28a3ece3-78fb-4121-86a7-adc4a9d9540f2025-07-21WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDEH E B28db9a27-4d23-48ef-b1f3-08b993948c112025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Kroger AntifungalTERBINAFINE HYDROCHLORIDEKroger Company32e79416-5de4-4f06-9fff-f8c36a1ad5db2025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEWALGREEN COMPANY2ba1924b-9967-4adb-9061-d023ef44ab3e2025-07-10WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDECardinal Health, 110 dba LEADERa9412747-c7f9-4242-91ed-3695f372f6c92025-07-09WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
AntifungalTERBINAFINE HYDROCHLORIDEMeijer Distribution Inc9daf3136-74b6-4410-8256-cbc9dd700f612025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ca9cd2bd-4805-4469-b754-01a7487b71a62025-07-01WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
012C11ZU6GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992528Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31f59302-eaee-211b-e063-6294a90a08b0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73469-7215-2Terbinafine Hydrochloride1 in 1 CARTONCREAM14
73469-7215-2Terbinafine Hydrochloride30 g in 1 TUBECREAM304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN31f59302-eaee-211b-e063-6294a90a08b04
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD31f59302-eaee-211b-e063-6294a90a08b04
992528terbinafine hydrochloride 1 % Topical CreamSY31f59302-eaee-211b-e063-6294a90a08b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73469-7215-2734697215021 TUBE in 1 CARTON (73469-7215-2) / 30 g in 1 TUBE1 tube2025-09-11NoNoCurrent