FDA.reportPublic FDA data

Capsaicin

Product NDC
50268-196
11-digit product format
502680196
Labeler code
50268
Product ID
50268-196_47e2fe8e-d7d1-12cb-e063-6294a90aa44b
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
AvPAK
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-08
Substance
CAPSAICIN
Active strength
.75 mg/g
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
Brand name suffix
Topical Analgesic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.75 mg/g

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
141868Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef597423-cd01-7324-e053-2a95a90aa1baAvailable 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
50268-196-57CapsaicinTopical Analgesic1 in 1 CARTONCREAM15
50268-196-57CapsaicinTopical Analgesic57 g in 1 TUBECREAM575

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-196-57GM - Gram50268-19636873346-3a79-4774-a1b5-2eb55fac7c6212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-196CAPSAICIN TOPICAL ANALGESIC (CAPSAICIN) CREAM [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240308_ef597423-cd01-7324-e053-2a95a90aa1ba.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 6 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-proprietary nameHEADACHE PATCHNanjing 3H Medical Products Co.,Ltd.586d73f1-0b0b-f596-e063-6394a90a4d572026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Dealmed BurnLIDOCAINEDealmed Medical Supplies, LLC.3b5f7ded-c275-4d7f-9fd4-539797d5507e2026-08-05WarningsExact identifier
application number: M017
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
Hempe HOT Muscle and Joint GelHEMPEHealthcare International Research Limited5854a80e-c92b-3ff5-e063-6294a90a2d052026-08-05WarningsExact identifier
application number: M017
Lidocaine Plantar Relief Roll-OnLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.585ccb4b-3bff-39b9-e063-6294a90a0e182026-08-05WarningsExact identifier
application number: M017
Green MARVEL PAIN RELIEFMENTHOL, CAMPHOR, METHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Lab9ff6e477-ef79-4a0c-9e21-8cae0e5d88102026-08-05WarningsExact 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
Wini By Locsanity Advanced Formula Muscle Joint Relief BalmMETHYL SALICYLATE,CAMPHOR,MENTHOLLocsanity LLC5829b5d7-78d4-78a2-e063-6394a90a3dfc2026-08-03WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141868capsaicin 0.075 % Topical CreamPSNef597423-cd01-7324-e053-2a95a90aa1ba5
141868capsaicin 0.75 MG/ML Topical CreamSCDef597423-cd01-7324-e053-2a95a90aa1ba5
141868capsaicin 0.075 % Topical CreamSYef597423-cd01-7324-e053-2a95a90aa1ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-196-57502680196571 TUBE in 1 CARTON (50268-196-57) / 57 g in 1 TUBE1 tube2022-12-080000-00-00NoNoCurrent