FDA.reportPublic FDA data

CVS Roll-On

Product NDC
51316-265
11-digit product format
513160265
Labeler code
51316
Product ID
51316-265_29574ffa-30bc-85fd-e063-6394a90a74d1
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaisin 0.1%
Dosage form
GEL
Route
TOPICAL
Labeler
CVS
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-22
Substance
CAPSAICIN
Active strength
.1 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
CVS Roll-On
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8812c49-335e-61ea-e053-2995a90a17aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-265-02CVS Roll-On71 g in 1 BOTTLE, PLASTICGEL713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-265CVS ROLL-ON (CAPSAISIN 0.1%) GEL [CVS]3Current NDC, 1 package rows20241217_e8812c49-335e-61ea-e053-2995a90a17aa.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 139 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017
Cool n HeatCOOL N HEATNeilMed Pharmaceuticals, Inc.a24cde17-280b-8358-e053-2a95a90af67d2024-01-11WarningsExact identifier
application number: M017
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
application number: M017
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
application number: M017
Cooling Itch ReliefCOOLING ITCH RELIEFNeilMed Pharmaceuticals, Inca24bdea0-18e8-8a5e-e053-2995a90acea22024-01-11WarningsExact identifier
application number: M017
Lightning X BurnLIDOCAINENantong Health & Beyond Hygienic Products Inc.0e69a971-0c6e-6ebe-e063-6394a90a0b332024-01-08WarningsExact identifier
application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
application number: M017
2nd CHANCE MOBILITY Pain ReliefHISTAMINE DIHYDROCHLORIDEALPHA NUTRITION, LLC575097ac-9fc9-4391-99d1-dff9b34817e32024-01-08WarningsExact identifier
application number: M017
Tiger Balm Arthritis RubCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.80932288-4797-40d3-aa8a-6af686fb67ad2024-01-08WarningsExact identifier
application number: M017
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
application number: M017
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-265-025131602650271 g in 1 BOTTLE, PLASTIC (51316-265-02) 71 g2022-12-22NoNoCurrent