FDA.reportPublic FDA data

Heat Pain Relief

Product NDC
0363-6263
11-digit product format
003636263
Labeler code
0363
Product ID
0363-6263_573476e6-fa30-0ae4-e063-6394a90a9130
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreen Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-28
Marketing end
2027-06-30
Substance
CAPSAICIN
Active strength
.1 g/100g
NDC exclude flag
No
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
Heat Pain Relief

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
646333Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2434f9cf-74aa-17af-e063-6294a90a56d9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6263-07Heat Pain Relief85 g in 1 APPLICATORCREAM852
0363-6263-07Heat Pain Relief1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6263HEAT PAIN RELIEF (CAPSAICIN 0.1%) CREAM [WALGREEN COMPANY]2Current NDC, 2 package rows20250406_2434f9cf-74aa-17af-e063-6294a90a56d9.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 47 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.4a24e813-6dbc-3fd1-e063-6294a90a4ff02026-01-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLVillage Pharma LLCd0ec7d25-ad58-46f2-b3b3-f13b4648b0b62026-01-01WarningsExact identifier
application number: M017
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLFSA Store Inc.47434af6-0fdd-9615-e063-6394a90ab9e82025-12-31WarningsExact identifier
application number: M017
Winco Lidocaine Pain Patch 4% 5ctLIDOCAINE PAIN PATCH 4%WINCO FOODS, LLC47439162-fc34-f0d0-e063-6394a90a29ab2025-12-31WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHQUEST USA CORP.1ad47834-4f8e-c692-e063-6294a90a7e772025-12-31WarningsExact identifier
application number: M017
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
application number: M017
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub LavenderCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company47473b24-a3e3-2858-e063-6394a90a59202025-12-31WarningsExact identifier
application number: M017
Eucerin Itch Relief Intensive CalmingMENTHOLBeiersdorf Inca7a78af1-1f5a-684d-e053-2a95a90a6ae92025-12-31WarningsExact identifier
application number: M017
Eucerin Skin Calming Itch Relief TreatmentMENTHOLBeiersdorf Inc7e568311-1e6b-9b4b-e053-2991aa0a7b672025-12-31WarningsExact identifier
application number: M017
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsExact identifier
application number: M017
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
application number: M017
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsExact identifier
application number: M017
Kroger Hot and Cold Medicated PatchMENTHOLKroger Company0331c1dd-fe30-421a-85a7-6c6886e7ab272025-12-30WarningsExact identifier
application number: M017
Menthol, CamphorMENTHOL, CAMPHORChemco Corporation472fb097-92e5-c230-e063-6294a90ab33a2025-12-30WarningsExact identifier
application number: M017
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact identifier
application number: M017
Nufabrx Elbow SleeveCAPSAICINNufabrx LLC473004cd-f7f9-3c68-e063-6294a90a5b8a2025-12-30WarningsExact identifier
application number: M017
Nufabrx Leg SleeveCAPSAICINNufabrx LLC473015ed-3e0f-6eae-e063-6294a90a4c742025-12-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646333capsaicin 0.1 % Topical CreamPSN2434f9cf-74aa-17af-e063-6294a90a56d92
646333capsaicin 1 MG/ML Topical CreamSCD2434f9cf-74aa-17af-e063-6294a90a56d92
646333capsaicin 0.1 % Topical CreamSY2434f9cf-74aa-17af-e063-6294a90a56d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6263-07003636263071 APPLICATOR in 1 CARTON (0363-6263-07) / 85 g in 1 APPLICATOR1 applicator2025-02-282027-06-30NoNoHistorical