FDA.reportPublic FDA data

SORE NO MORE

Product NDC
61577-2280
Requested package NDC
61577-2280-4
11-digit product format
615772280
Labeler code
61577
Product ID
61577-2280_4d785eb6-f915-92cc-e063-6294a90ad2f4
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-25
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.03; .03 g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 7 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…

Additional Listing Data#

Finished product
Yes
Brand name base
SORE NO MORE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.03 g/g
CAMPHOR (SYNTHETIC).03 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630714Internal RxNorm lookup
1372559Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61577-2280-22025-01-30Glo Germ SORE NO MORE
61577-2280-42025-01-30Glo Germ SORE NO MORE
61577-2280-52025-01-30Glo Germ SORE NO MORE
61577-2280-82025-01-30Glo Germ SORE NO MORE
61577-2280-22023-03-08Glo Germ SORE NO MORE
61577-2280-42023-03-08Glo Germ SORE NO MORE
61577-2280-52023-03-08Glo Germ SORE NO MORE
61577-2280-82023-03-08Glo Germ SORE NO MORE
61577-2280-22023-01-30Glo Germ SORE NO MORE
61577-2280-42023-01-30Glo Germ SORE NO MORE
61577-2280-52023-01-30Glo Germ SORE NO MORE
61577-2280-82023-01-30Glo Germ SORE NO MORE
61577-2280-22020-03-06Glo Germ SORE NO MORE
61577-2280-42020-03-06Glo Germ SORE NO MORE
61577-2280-52020-03-06Glo Germ SORE NO MORE
61577-2280-82020-03-06Glo Germ SORE NO MORE
61577-2280-22020-01-31Glo Germ SORE NO MORE
61577-2280-42020-01-31Glo Germ SORE NO MORE
61577-2280-52020-01-31Glo Germ SORE NO MORE
61577-2280-82020-01-31Glo Germ SORE NO MORE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-2280-2SORE NO MORE58.7 g in 1 JARGEL58.77
61577-2280-4SORE NO MORE113.4 g in 1 JARGEL113.47
61577-2280-5SORE NO MORE5 g in 1 POUCHGEL57
61577-2280-6SORE NO MORE18200 g in 1 PAILGEL182007
61577-2280-8SORE NO MORE226.8 g in 1 JARGEL226.87

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ASORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ASORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
CAPSICUMINACTIVE INGREDIENT00UK7646FGSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6SORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
ORANGE PEELINACTIVE INGREDIENTTI9T76XD44SORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
WITCH HAZELINACTIVE INGREDIENT101I4J0U34SORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATSORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-2280SORE NO MORE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]5Current NDC, Legacy NDC, 5 package rows20230309_80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd.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 1 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.56e36592-a935-61d4-e063-6294a90a6e4c2026-08-04WarningsExact identifier
application number: M017
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
application number: M017
procureHYDROCORTISONE ACETATETWIN MED, LLC2670c9c4-66ad-40e8-a08a-582b160de39d2026-08-03WarningsExact identifier
application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Alphamale Delay CreamBENZOCAINEProdigy Media Inc53d682ee-0802-a16d-e063-6394a90aeee12026-07-31WarningsExact identifier
application number: M017
Pure Primal Delay CreamBENZOCAINEProdigy Media Inc57e9e894-c14f-d806-e063-6394a90ab8e52026-07-31WarningsExact identifier
application number: M017
SatohapDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.df0e2b83-8f61-4ed8-bcc4-55e4ea7820902026-07-31WarningsExact identifier
application number: M017
SatogesicDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.cb000134-92a4-4304-8ef0-0347190e14142026-07-31WarningsExact identifier
application number: M017
Satogesic HotCAPSAICINSato Pharmaceutical Co., Ltd.16b47cb5-ea5f-4514-9a89-141ee4cc60f82026-07-31WarningsExact identifier
application number: M017
Satohap Cool and Hot PadsCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceutical Co., Ltd.b6bf1eab-4ab9-f500-e053-2995a90a8d7b2026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
SATOHAP COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630714camphor 3 % / menthol 3 % Topical GelPSN80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7
1372559Sore No More 3 % / 3 % Topical GelPSN80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7
1372559camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel [Sore No More]SBD80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCD80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7
630714camphor 3 % / menthol 3 % Topical GelSY80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7
1372559Sore No More (camphor 3 % / menthol 3 % ) Topical GelSY80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-2280-461577228004113.4 g in 1 JAR (61577-2280-4) 113.4 g2016-10-250000-00-00NoNoCurrent