FDA.reportPublic FDA data

FOOT

Product NDC
72609-703
11-digit product format
726090703
Labeler code
72609
Product ID
72609-703_45c89ca7-3353-d315-e063-6394a90ac647
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Smith Amish, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-28
Substance
MENTHOL
Active strength
1.25 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20c48537-f55f-c10f-e063-6394a90a4ccaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72609-703-022025-07-29C16284748780-13b156c62-2843-fb37-e063-e6dba90a4e07Smith Amish Foot Cream (2oz) - 72609-703-02; Smith Amish Foot Cream (4oz) - 72609-703-04
72609-703-022025-07-29C16284748780-13b156c62-2843-fb37-e063-e6dba90a4e07Smith Amish Foot Cream (2oz) - 72609-703-02; Smith Amish Foot Cream (4oz) - 72609-703-04
72609-703-022025-07-29C16284748780-13b156c62-2843-fb37-e063-e6dba90a4e07Smith Amish Foot Cream (2oz) - 72609-703-02; Smith Amish Foot Cream (4oz) - 72609-703-04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72609-703-02FOOT59 g in 1 TUBECREAM596
72609-703-02FOOT1 in 1 BOXCREAM16
72609-703-04FOOT123 g in 1 JARCREAM1236

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72609-703FOOT (MENTHOL) CREAM [SMITH AMISH, LLC]2Current NDC, 3 package rows20241115_20c48537-f55f-c10f-e063-6394a90a4cca.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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSN20c48537-f55f-c10f-e063-6394a90a4cca6
416982menthol 12.5 MG/ML Topical CreamSCD20c48537-f55f-c10f-e063-6394a90a4cca6
416982menthol 1.25 % Topical CreamSY20c48537-f55f-c10f-e063-6394a90a4cca6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72609-703-02726090703021 TUBE in 1 BOX (72609-703-02) / 59 g in 1 TUBE1 tube2024-08-28NoNoCurrent
72609-703-0472609070304123 g in 1 JAR (72609-703-04) 123 g2025-08-01NoNoCurrent