PBZ OTC

Product NDC
69993-151
11-digit product format
699930151
Labeler code
69993
Product ID
69993-151_d144cc3d-1fca-4a3e-932c-7ca07b85068b
Type
HUMAN OTC DRUG
Nonproprietary name
Tripelennamine HCl 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Kingsway Pharmaceuticals dba NFI, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
TRIPELENNAMINE
Active strength
1 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
PBZ OTC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIPELENNAMINE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3C5ORO99TYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2711712Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12f72d74-018f-4bc6-acd4-175ca3af4c6dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69993-151-01PBZ OTC1 in 1 CARTONCREAM13
69993-151-01PBZ OTC28 g in 1 TUBECREAM283
69993-151-02PBZ OTC3.25 g in 1 POUCHCREAM3.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69993-151PBZ OTC (TRIPELENNAMINE HCL 1%) CREAM [KINGSWAY PHARMACEUTICALS DBA NFI, LLC]2Current NDC, 3 package rows20250413_12f72d74-018f-4bc6-acd4-175ca3af4c6d.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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711712tripelennamine HCl 1 % Topical CreamPSN12f72d74-018f-4bc6-acd4-175ca3af4c6d3
2711712tripelennamine hydrochloride 10 MG/ML Topical CreamSCD12f72d74-018f-4bc6-acd4-175ca3af4c6d3
2711712tripelennamine hydrochloride 1 % Topical CreamSY12f72d74-018f-4bc6-acd4-175ca3af4c6d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69993-151-01699930151011 TUBE in 1 CARTON (69993-151-01) / 28 g in 1 TUBE1 tube2025-02-01NoNoCurrent
69993-151-02699930151023.25 g in 1 POUCH (69993-151-02) 3.25 g2025-02-01YesNoCurrent