FDA.reportPublic FDA data

NDC 61577-3216-8

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61577-3216
Requested NDC
61577-3216-8
Package NDCs from labels
61577-3216-8
Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61577-3216-12025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-12025-05-27Vitality Extracts Warm Pain Relief
61577-3216-12025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-22025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-22025-05-27Vitality Extracts Warm Pain Relief
61577-3216-22025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-32025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-32025-05-27Vitality Extracts Warm Pain Relief
61577-3216-32025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-42025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-42025-05-27Vitality Extracts Warm Pain Relief
61577-3216-42025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-52025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-52025-05-27Vitality Extracts Warm Pain Relief
61577-3216-52025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-62025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-62025-05-27Vitality Extracts Warm Pain Relief
61577-3216-62025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-72025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-72025-05-27Vitality Extracts Warm Pain Relief
61577-3216-72025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-92025-05-27ScripHessco Warm Therapy Pain Relief
61577-3216-92025-05-27Vitality Extracts Warm Pain Relief
61577-3216-92025-05-27Santa Calma Plus Warming Pain Relief
61577-3216-12025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-12025-01-30Vitality Extracts Warm Pain Relief
61577-3216-12025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-22025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-22025-01-30Vitality Extracts Warm Pain Relief
61577-3216-22025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-32025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-32025-01-30Vitality Extracts Warm Pain Relief
61577-3216-32025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-42025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-42025-01-30Vitality Extracts Warm Pain Relief
61577-3216-42025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-52025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-52025-01-30Vitality Extracts Warm Pain Relief
61577-3216-52025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-62025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-62025-01-30Vitality Extracts Warm Pain Relief
61577-3216-62025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-72025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-72025-01-30Vitality Extracts Warm Pain Relief
61577-3216-72025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-92025-01-30ScripHessco Warm Therapy Pain Relief
61577-3216-92025-01-30Vitality Extracts Warm Pain Relief
61577-3216-92025-01-30Santa Calma Plus Warming Pain Relief
61577-3216-12020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-12020-03-05Vitality Extracts Warm Pain Relief
61577-3216-12020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-22020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-22020-03-05Vitality Extracts Warm Pain Relief
61577-3216-22020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-32020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-32020-03-05Vitality Extracts Warm Pain Relief
61577-3216-32020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-42020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-42020-03-05Vitality Extracts Warm Pain Relief
61577-3216-42020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-52020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-52020-03-05Vitality Extracts Warm Pain Relief
61577-3216-52020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-62020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-62020-03-05Vitality Extracts Warm Pain Relief
61577-3216-62020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-72020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-72020-03-05Vitality Extracts Warm Pain Relief
61577-3216-72020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-92020-03-05ScripHessco Warm Therapy Pain Relief
61577-3216-92020-03-05Vitality Extracts Warm Pain Relief
61577-3216-92020-03-05Santa Calma Plus Warming Pain Relief
61577-3216-12020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-12020-01-31Vitality Extracts Warm Pain Relief
61577-3216-12020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-22020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-22020-01-31Vitality Extracts Warm Pain Relief
61577-3216-22020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-32020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-32020-01-31Vitality Extracts Warm Pain Relief
61577-3216-32020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-42020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-42020-01-31Vitality Extracts Warm Pain Relief
61577-3216-42020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-52020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-52020-01-31Vitality Extracts Warm Pain Relief
61577-3216-52020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-62020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-62020-01-31Vitality Extracts Warm Pain Relief
61577-3216-62020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-72020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-72020-01-31Vitality Extracts Warm Pain Relief
61577-3216-72020-01-31Santa Calma Plus Warming Pain Relief
61577-3216-92020-01-31ScripHessco Warm Therapy Pain Relief
61577-3216-92020-01-31Vitality Extracts Warm Pain Relief
61577-3216-92020-01-31Santa Calma Plus Warming Pain Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-3216SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]8Legacy NDC20250529_de78dba9-53b3-4dbd-9dd2-6a692378da34.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61577-3216-2GM - Gram61577-321650682f2e-b232-4b7e-bcc7-5d0d4955829c12021-07-15
61577-3216-3GM - Gram61577-3216ba719732-ef7b-43e2-95cb-2d6126fb564812017-05-04
61577-3216-4GM - Gram61577-3216dae72463-5d76-4028-abb6-e55b7093880b12015-10-02
61577-3216-5GM - Gram61577-3216d2945157-6ab8-4cce-b4cb-9b07a286623312016-11-08
61577-3216-8GM - Gram61577-32163aa85f2f-9690-489b-b31d-3c4a62e4e3b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
MENTHOLACTIVE INGREDIENTL7T10EIP3ASOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3ASOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CAPSICUMINACTIVE INGREDIENT00UK7646FGSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ORANGE PEELINACTIVE INGREDIENTTI9T76XD44SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
WITCH HAZELINACTIVE INGREDIENT101I4J0U34SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4

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 1 of 45 · 900 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsName fallback
generic name: MENTHOL
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsName fallback
generic name: MENTHOL
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsName fallback
generic name: MENTHOL
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsName fallback
generic name: MENTHOL
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsName fallback
generic name: MENTHOL
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsName fallback
generic name: MENTHOL
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsName fallback
generic name: MENTHOL
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsName fallback
generic name: MENTHOL
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsName fallback
generic name: MENTHOL
Best Health Caramel Apple Cough DropsMENTHOLBestco58eee9b4-d696-995f-e063-6294a90a5db02026-08-13WarningsName fallback
generic name: MENTHOL
Best Health Pumpkin Spice Cough DropsMENTHOLBestco58ef6619-9087-5f41-e063-6294a90a7da62026-08-13WarningsName fallback
generic name: MENTHOL
Best Health Bourbon Honey Cough DropsMENTHOLBestco58efdf29-83ea-03b9-e063-6294a90ad3062026-08-13WarningsName fallback
generic name: MENTHOL
Best Health Maple Spice Cough DropsMENTHOLBestco58cfdacb-c713-220f-e063-6394a90acbfc2026-08-11WarningsName fallback
generic name: MENTHOL
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsName fallback
generic name: MENTHOL
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsName fallback
generic name: MENTHOL
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsName fallback
generic name: MENTHOL
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsName fallback
generic name: MENTHOL
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsName fallback
generic name: MENTHOL
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsName fallback
generic name: MENTHOL
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsName fallback
generic name: MENTHOL

Reported adverse events (FAERS/openFDA)#

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