Capsaicin

Product NDC
50488-1025
11-digit product format
504881025
Labeler code
50488
Product ID
50488-1025_1eb282ca-46c9-4da5-b2e8-40819f4a6677
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
CAPSAICIN
Active strength
.025 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
Capsaicin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 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
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
433da27d-04fb-481a-bbb0-874bb72c806aAvailable 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
50488-1025-1Capsaicin1 in 1 CARTONCREAM16
50488-1025-1Capsaicin120 g in 1 TUBECREAM1206
50488-1025-2Capsaicin1 in 1 CARTONCREAM16
50488-1025-2Capsaicin25 g in 1 TUBECREAM256
50488-1025-5Capsaicin1 in 1 CARTONCREAM16
50488-1025-5Capsaicin50 g in 1 TUBECREAM506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1025-1GM - Gram50488-1025d17846c1-27c2-4422-951e-81c30af4e47b12018-11-06
50488-1025-2GM - Gram50488-1025990eddfb-a7a5-4493-b6e9-371140c2fd9d12019-10-07
50488-1025-5GM - Gram50488-10259795f0e9-7933-4d81-9bc2-c7b3efa42c3812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1025CAPSAICIN CREAM [ALEXSO, INC]6Current NDC, Legacy NDC, 6 package rows20241208_433da27d-04fb-481a-bbb0-874bb72c806a.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 106 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact identifier
application number: M017
OKeeffes Working Hands Pain Relief Skin ProtectantALLANTOIN, LIDOCAINE HYDROCHLORIDEThe Gorilla Glue Company/O'Keeffe's Company0685da25-c9fa-e1cd-e063-6394a90ae1b32025-01-01WarningsExact identifier
application number: M017
Icy Hot with Lidocaine Pain RelievingLIDOCAINE HCL AND MENTHOLChattem, Inc.75b28b06-77ea-4fea-b516-2e8a0dac70372025-01-01WarningsExact identifier
application number: M017
Advanced Seal Barrier plus Pain ReliefLIDOCAINEKericure Inc.7ac95325-e6e9-4c56-9315-876c00af7c982025-01-01WarningsExact identifier
application number: M017
FixMySkin Healing Balm Fragrance-FreeHYDROCORTISONELovely Skin, Inc.c12af4c6-2f05-46ec-b901-1a4fcd7501802024-12-31WarningsExact identifier
application number: M017
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
application number: M017
Cold Therapy Pain Relief WalgreensMENTHOL 10.5%WALGREEN COMPANYf1daa68d-1b12-c28a-e053-2995a90a09492024-12-31WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN433da27d-04fb-481a-bbb0-874bb72c806a6
198555capsaicin 0.25 MG/ML Topical CreamSCD433da27d-04fb-481a-bbb0-874bb72c806a6
198555capsaicin 0.025 % Topical CreamSY433da27d-04fb-481a-bbb0-874bb72c806a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1025-1504881025011 TUBE in 1 CARTON (50488-1025-1) / 120 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent
50488-1025-2504881025021 TUBE in 1 CARTON (50488-1025-2) / 25 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent
50488-1025-5504881025051 TUBE in 1 CARTON (50488-1025-5) / 50 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent