Capsaicin

Product NDC
76420-753
11-digit product format
764200753
Labeler code
76420
Product ID
76420-753_1b4cad2b-3896-f700-e063-6394a90a2fa5
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-08
Substance
CAPSAICIN
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Capsaicin
Listing expiration
2027-12-31

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 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
97d506bd-3215-4e2e-9914-af1c174dd4abAvailable 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
76420-753-42Capsaicin42.5 g in 1 TUBECREAM42.51
76420-753-42Capsaicin1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-753CAPSAICIN CREAM [ASCLEMED USA, INC.]1Current NDC, 2 package rows20240622_97d506bd-3215-4e2e-9914-af1c174dd4ab.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 114 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMG PAIN RELIEF BODYLIDOCAINEPOMG LLC28d7ac46-b27f-43bb-e063-6294a90a93ed2024-12-06WarningsExact identifier
application number: M017
Capsaicin 0.1 PercentCAPSAICINAlexso, Inc0090ca38-6433-45c4-9453-edf2788c14c62024-12-06WarningsExact identifier
application number: M017
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646333capsaicin 0.1 % Topical CreamPSN97d506bd-3215-4e2e-9914-af1c174dd4ab1
646333capsaicin 1 MG/ML Topical CreamSCD97d506bd-3215-4e2e-9914-af1c174dd4ab1
646333capsaicin 0.1 % Topical CreamSY97d506bd-3215-4e2e-9914-af1c174dd4ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-753-42764200753421 TUBE in 1 CARTON (76420-753-42) / 42.5 g in 1 TUBE1 tube2024-06-20NoNoCurrent