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 150 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS NATURAL PAINMENTHOLThe Feel Good Lab778b62a1-ebd3-4a30-8f76-6d6773b698c52023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLThe Feel Good Lab103c5e33-42fb-41ac-957e-bb46d85e204c2023-11-05WarningsExact identifier
application number: M017
INSTA RELIEF DMLIDOCAINE HYDROCHLORIDE, MENTHOLDM LAB CORP6ef66fb9-9f49-409d-9503-175c7555ee9e2023-11-05WarningsExact identifier
application number: M017
DR. MIKES Ponos Pain Relief Cream Roll-OnHISTAMINE DIHYDROCHLORIDE, MENTHOLDr. Mike's Vitamins, LLCfcc45464-f1fe-4244-95a7-9b4288b0ce452023-11-05WarningsExact identifier
application number: M017
AcuPlus Pain ReliefMENTHOLInnovations for Wellness, LLC7f222a4f-85a8-4f3d-aa97-5c695d4da37f2023-11-05WarningsExact identifier
application number: M017
Ana Cool Rapid Soothing Cooling FormulaHYDROCORTISONEAna-Cool, LLC64b80cc2-e2d8-4535-aaf8-c031f4159cd12023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLTHE FEEL GOOD LAB, LLC19b08cbf-5f43-4f07-8f4d-8cddb1492ab82023-11-05WarningsExact identifier
application number: M017
PlayMakar Roll On Cool Pain ReliefMENTHOLPlayMakar Inc.a12c16e7-561f-45a7-93c6-34d693ffdc7c2023-11-05WarningsExact identifier
application number: M017
AcuPlus Advanced Therapy for Pain and RecoveryMENTHOLINNOVATIONS FOR WELLNESS, LLC840cfd15-4ea1-49bf-8c4f-86c12461d8602023-11-05WarningsExact identifier
application number: M017
SCLERA CARE Topical Anesthetic GelLIDOCAINE HYDROCHLORIDEScleraCare, LLC488ace02-fc0b-4d13-ab89-0e1640e915e52023-11-05WarningsExact identifier
application number: M017
IRELIEV ROLL ON COOL PAIN RELIEFMENTHOLExcel Health, Incdab94995-7393-4d9c-b295-72611a90919b2023-11-05WarningsExact identifier
application number: M017
URIFLEX Fast Acting Analgesic Pain ReliefMENTHOLRejuvica LLCfb78f705-b838-461d-b42c-8c98d3ca5d092023-11-05WarningsExact identifier
application number: M017
365 Medicated Lip BalmMEDICATED LIP BALMWhole Foods Market, Inc.48309a7d-d2da-483c-8bf8-f59d9ad0bb732023-11-03WarningsExact 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