FDA.reportPublic FDA data

Sombra Max

Product NDC
61577-3440
11-digit product format
615773440
Labeler code
61577
Product ID
61577-3440_41623a46-e6e8-907e-e063-6394a90afc4c
Type
HUMAN OTC DRUG
Nonproprietary name
Sombra Max
Dosage form
CREAM
Route
TOPICAL
Labeler
Sombra Cosmetics Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
MENTHOL GLUCURONIDE; HISTAMINE DIHYDROCHLORIDE; CAMPHOR (SYNTHETIC); CAPSAICIN; METHYL SALICYLATE
Active strength
6; .025; 3; .025; 12 g/100g; g/100g; g/100g; g/100g; g/100g
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
Sombra Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL GLUCURONIDE6 g/100g
HISTAMINE DIHYDROCHLORIDE.025 g/100g
CAMPHOR (SYNTHETIC)3 g/100g
CAPSAICIN.025 g/100g
METHYL SALICYLATE12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WW64GZ6LQYInternal UNII lookup
3POA0Q644UInternal UNII lookup
5TJD82A1ETInternal UNII lookup
S07O44R1ZMInternal 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
41623a46-e6e7-907e-e063-6394a90afc4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3440-1Sombra Max1 g in 1 CONTAINERCREAM11
61577-3440-2Sombra Max1 g in 1 PACKETCREAM11

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 80 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61577-3440-1615773440011 g in 1 CONTAINER (61577-3440-1) 1 g2026-01-01NoNoCurrent
61577-3440-2615773440021 g in 1 PACKET (61577-3440-2) 1 g2026-01-01NoNoCurrent