FDA.reportPublic FDA data

SOMBRA COOL THERAPY

Product NDC
61577-3221
Requested package NDC
61577-3221-3
11-digit product format
615773221
Labeler code
61577
Product ID
61577-3221_5fe37a57-1a13-4f93-af5a-9c1899c2c066
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-05-17
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61577-322161577-3221-3DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61577-3221-12025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-12025-05-27Vitality Extracts Cool Pain Relief
61577-3221-12025-05-27321 Cool Pain Relief
61577-3221-22025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-22025-05-27Vitality Extracts Cool Pain Relief
61577-3221-22025-05-27321 Cool Pain Relief
61577-3221-32025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-32025-05-27Vitality Extracts Cool Pain Relief
61577-3221-32025-05-27321 Cool Pain Relief
61577-3221-42025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-42025-05-27Vitality Extracts Cool Pain Relief
61577-3221-42025-05-27321 Cool Pain Relief
61577-3221-62025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-62025-05-27Vitality Extracts Cool Pain Relief
61577-3221-62025-05-27321 Cool Pain Relief
61577-3221-72025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-72025-05-27Vitality Extracts Cool Pain Relief
61577-3221-72025-05-27321 Cool Pain Relief
61577-3221-92025-05-27ScripHessco Cool Therapy Pain Relief
61577-3221-92025-05-27Vitality Extracts Cool Pain Relief
61577-3221-92025-05-27321 Cool Pain Relief
61577-3221-12025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-12025-01-30Vitality Extracts Cool Pain Relief
61577-3221-12025-01-30321 Cool Pain Relief
61577-3221-22025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-22025-01-30Vitality Extracts Cool Pain Relief
61577-3221-22025-01-30321 Cool Pain Relief
61577-3221-32025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-32025-01-30Vitality Extracts Cool Pain Relief
61577-3221-32025-01-30321 Cool Pain Relief
61577-3221-42025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-42025-01-30Vitality Extracts Cool Pain Relief
61577-3221-42025-01-30321 Cool Pain Relief
61577-3221-62025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-62025-01-30Vitality Extracts Cool Pain Relief
61577-3221-62025-01-30321 Cool Pain Relief
61577-3221-72025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-72025-01-30Vitality Extracts Cool Pain Relief
61577-3221-72025-01-30321 Cool Pain Relief
61577-3221-92025-01-30ScripHessco Cool Therapy Pain Relief
61577-3221-92025-01-30Vitality Extracts Cool Pain Relief
61577-3221-92025-01-30321 Cool Pain Relief
61577-3221-12020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-12020-03-05Vitality Extracts Cool Pain Relief
61577-3221-12020-03-05321 Cool Pain Relief
61577-3221-22020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-22020-03-05Vitality Extracts Cool Pain Relief
61577-3221-22020-03-05321 Cool Pain Relief
61577-3221-32020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-32020-03-05Vitality Extracts Cool Pain Relief
61577-3221-32020-03-05321 Cool Pain Relief
61577-3221-42020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-42020-03-05Vitality Extracts Cool Pain Relief
61577-3221-42020-03-05321 Cool Pain Relief
61577-3221-52020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-52020-03-05Vitality Extracts Cool Pain Relief
61577-3221-52020-03-05321 Cool Pain Relief
61577-3221-62020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-62020-03-05Vitality Extracts Cool Pain Relief
61577-3221-62020-03-05321 Cool Pain Relief
61577-3221-72020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-72020-03-05Vitality Extracts Cool Pain Relief
61577-3221-72020-03-05321 Cool Pain Relief
61577-3221-92020-03-05ScripHessco Cool Therapy Pain Relief
61577-3221-92020-03-05Vitality Extracts Cool Pain Relief
61577-3221-92020-03-05321 Cool Pain Relief
61577-3221-12020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-12020-01-31Vitality Extracts Cool Pain Relief
61577-3221-12020-01-31321 Cool Pain Relief
61577-3221-22020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-22020-01-31Vitality Extracts Cool Pain Relief
61577-3221-22020-01-31321 Cool Pain Relief
61577-3221-32020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-32020-01-31Vitality Extracts Cool Pain Relief
61577-3221-32020-01-31321 Cool Pain Relief
61577-3221-42020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-42020-01-31Vitality Extracts Cool Pain Relief
61577-3221-42020-01-31321 Cool Pain Relief
61577-3221-52020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-52020-01-31Vitality Extracts Cool Pain Relief
61577-3221-52020-01-31321 Cool Pain Relief
61577-3221-62020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-62020-01-31Vitality Extracts Cool Pain Relief
61577-3221-62020-01-31321 Cool Pain Relief
61577-3221-72020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-72020-01-31Vitality Extracts Cool Pain Relief
61577-3221-72020-01-31321 Cool Pain Relief
61577-3221-92020-01-31ScripHessco Cool Therapy Pain Relief
61577-3221-92020-01-31Vitality Extracts Cool Pain Relief
61577-3221-92020-01-31321 Cool Pain Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61577-3221-2GM - Gram61577-3221eb743e0c-06f1-4c88-b0bd-d711edb28d8a12015-10-02
61577-3221-3GM - Gram61577-3221797c6f46-4777-4773-8c48-fbfb370a4f7d12017-05-04
61577-3221-4GM - Gram61577-322144fb8205-8c2a-4e9c-89fe-4abc8628792212012-07-24
61577-3221-7GM - Gram61577-3221e68592a1-87b9-4fdf-89ae-7b309b6c908912024-05-16
61577-3221-8GM - Gram61577-3221bfbc6029-8098-48d0-b93b-8e61a98ccdf712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ASOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ASOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
LEMON PEELINACTIVE INGREDIENT72O054U628SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
WITCH HAZELINACTIVE INGREDIENT101I4J0U34SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-3221SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]8Legacy NDC20250529_87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-3221-361577322103226.8 g in 1 JAR (61577-3221-3) 226.8 g2022-05-170000-00-00NoNoCurrent