FDA.reportPublic FDA data

Extra Strength

Product NDC
69204-027
11-digit product format
692040027
Labeler code
69204
Product ID
69204-027_297f0ddf-6d38-b182-e063-6394a90a6570
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
NATURES FORMULAE HEALTH PRODUCTS LTD.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-13
Substance
MENTHOL; METHYL SALICYLATE
Active strength
94.41; 123.74 mg/mL; 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
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL94.41 mg/mL
METHYL SALICYLATE123.74 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d919b50a-5de2-1830-e053-2a95a90ab88dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-027-01Extra Strength1 in 1 BOXOIL12
69204-027-01Extra Strength45 mL in 1 BOTTLE, WITH APPLICATOROIL452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-027EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]2Current NDC, Legacy NDC, 2 package rows20241220_d919b50a-5de2-1830-e053-2a95a90ab88d.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 150 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
application number: M017
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bbee66b9-39ff-4e7e-e053-2995a90a43be2023-10-25WarningsExact identifier
application number: M017
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
application number: M017
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.cddc9c4a-7c58-4225-921a-05d6afb491782023-10-24WarningsExact identifier
application number: M017
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
application number: M017
Numfast Tetracaine GreenTETRACAINEUnit Dose, Ltd.77d9e6ea-1cd3-4447-ba74-01cd7143e27c2023-10-19WarningsExact identifier
application number: M017
LiprotekPETROLATUM, LIDOCAINEUnit Dose, Ltd.051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa52023-10-19WarningsExact identifier
application number: M017
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
application number: M017
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69204-027-01692040027011 BOTTLE, WITH APPLICATOR in 1 BOX (69204-027-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR2019-05-130000-00-00NoNoCurrent