FDA.reportPublic FDA data

LactiGo

Product NDC
72481-101
11-digit product format
724810101
Labeler code
72481
Product ID
72481-101_213e8489-762b-461f-e063-6394a90a64a3
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
LactiGo, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-21
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
12.5 mg/mL
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
LactiGo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM12.5 mg/mL

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
866128Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
849c3601-2bc8-0991-e053-2a91aa0a5e7fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72481-101-03LactiGo100 mL in 1 BOTTLE, PUMPGEL1004
72481-101-32LactiGo946 mL in 1 BOTTLE, PUMPGEL9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72481-101LACTIGO (MENTHOL) GEL [LACTIGO, INC.]4Current NDC, Legacy NDC, 2 package rows20240905_849c3601-2bc8-0991-e053-2a91aa0a5e7f.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
866128menthol 1.25 % Topical GelPSN849c3601-2bc8-0991-e053-2a91aa0a5e7f4
866128menthol 0.0125 MG/MG Topical GelSCD849c3601-2bc8-0991-e053-2a91aa0a5e7f4
866128menthol 1.25 % Topical GelSY849c3601-2bc8-0991-e053-2a91aa0a5e7f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72481-101-0372481010103100 mL in 1 BOTTLE, PUMP (72481-101-03) 100 ml2019-03-210000-00-00NoNoCurrent
72481-101-3272481010132946 mL in 1 BOTTLE, PUMP (72481-101-32) 946 ml2024-08-30NoNoCurrent