EFAC

Product NDC
55722-419
11-digit product format
557220419
Labeler code
55722
Product ID
55722-419_9cdba220-6919-4ba3-b6d6-e71d63f01360
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Imagenetix
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
13 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55722-419DDiscontinued by firm2026-07-31
excluded packagepackage55722-41955722-419-02DDiscontinued by firm2026-07-31

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
hydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.12cd35e3-e707-4551-b778-bf615c1a8d322026-05-11WarningsExact identifier
Arthritis Pain Relieving CreamMENTHOL, METHYL SALICYLATEInternational Nature Nutraceuticals, Inc.2c9d070c-bf90-4482-8a6e-c7491cdd34c52025-12-27WarningsExact identifier
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLPreferred Pharmaceuticals Inc.186445d4-ef73-4d34-849d-4661a3eaa43a2025-09-30WarningsExact identifier
TerocinLIDOCAINE, MENTHOLPreferred Pharmaceuticals, Inc.23843354-e242-4a8a-8818-897592d4d9a02025-09-30WarningsExact identifier
Discount Drug Mart Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEDiscount Drug Mart8748c31d-8258-0357-e053-2a95a90a9c222019-04-24WarningsExact identifier
Best Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEValu Merchandisers873591ef-16cb-ab90-e053-2991aa0a865d2019-04-23WarningsExact identifier
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
Discount Drug Mart Anti-itchHYDROCORTISONEDISCOUNT DRUG MART, INC.853eee29-6f57-59d4-e053-2991aa0aa6112019-03-29WarningsExact identifier
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
Instaflex Pain Relief CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
Capsaicin Pain ReliefCAPSAICINKareway Product, Inc.dce9db37-cd07-44d8-8881-f63a2191964f2018-06-07WarningsExact identifier
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
Avedana Cool Hot IceMENTHOLUnipack, Inc.619c8e3f-0cad-4eb1-8dbb-632f3db74ba32018-05-01WarningsExact identifier
SunBurnt PLUS Pain ReliefLIDOCAINE HYDROCHLORIDEWelmedix LLC dba Welmedix Consumer Healthcare6363c695-f801-407d-a4e1-b0d9cfa0a2732018-03-13WarningsExact identifier
Pure-AidLIDOCAINE, MENTHOLKareway Product, Inc.6679cada-f083-26e8-e053-2a91aa0adcc52018-03-02WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Avoid contact with eyes and mucous membranes • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. • Do not apply to wounds or damaged skin. • Do not apply bandage tightly. • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. • Discontinue use if excessive irritation of skin develops. • If pregnant or breast feeding, ask a health professional before use. • A temporary burning sensation may occur upon application, but generally disappears in a few days.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55722-419-022023-03-21C16284748780-19855d018-da72-cd31-e053-dbdaa90ab51aEFAC Pain Relieving Cream
55722-419-022019-11-27C16284748780-19855d018-da72-cd31-e053-dbdaa90ab51aEFAC Pain Relieving Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
MentholACTIVE MOIETYL7T10EIP3AEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999REFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1
WATERINACTIVE INGREDIENT059QF0KO0REFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]1