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
Ingredient	Strength
TRIPELENNAMINE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3C5ORO99TY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
12f72d74-018f-4bc6-acd4-175ca3af4c6d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69993-151-01	PBZ OTC	1 in 1 CARTON	CREAM	1	3
69993-151-01	PBZ OTC	28 g in 1 TUBE	CREAM	28	3
69993-151-02	PBZ OTC	3.25 g in 1 POUCH	CREAM	3.25	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69993-151	PBZ OTC (TRIPELENNAMINE HCL 1%) CREAM [KINGSWAY PHARMACEUTICALS DBA NFI, LLC]	2	Current NDC, 3 package rows	20250413_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 131 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON	PAIN RELIEF HEAT THERAPY ROLL-ON	Shenzhen Sam Technology Co., Ltd.	1d0b7b8f-9e5d-00f7-e063-6394a90af87c	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.	PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0b94ec-f956-dff2-e063-6294a90aca4a	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.	PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0bf4f9-6b02-6cec-e063-6294a90a36c7	2024-07-12	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE HCI 2.0%	Trifecta Pharmaceuticals USA, LLC.	e5e524cd-bb22-715f-e053-2995a90ab5d3	2024-07-12	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	1d10e3ca-dc93-8e1a-e063-6394a90a47c0	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.	PAIN RELIEF HEAT THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d199826-1b27-b6e7-e063-6394a90a69ad	2024-07-12	Warnings	Exact identifier application number: M017
Tidl Pain Relief Morning Therapy Spray.	PAIN RELIEF MORNING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d19d070-3818-73de-e063-6394a90a8958	2024-07-12	Warnings	Exact identifier application number: M017
Hydrocortisone with aloe	HYDROCORTISONE WITH ALOE ANTI ITCH	NeilMed Pharmaceuticals Inc.	032b9f58-5f64-04dd-e063-6294a90a6bb9	2024-07-10	Warnings	Exact identifier application number: M017
Octagon Pain Relief	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	9926f733-1506-4224-9d70-b1813cd81ec3	2024-07-08	Warnings	Exact identifier application number: M017
LidoReal Patch	LIDOCAINE AND MENTHOL	FORREAL PHARMACEUTICALS LLC	19f1c037-b4b8-47b0-b0f9-036691c1d307	2024-07-05	Warnings	Exact identifier application number: M017
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM	MENTHOL	L'Oreal USA Products Inc	d580982f-dda6-4b03-bf84-342b9f2c6d93	2024-06-29	Warnings	Exact identifier application number: M017
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier application number: M017
10% Methyl Salicylate Pain Relief Patch	10% METHYL SALICYLATE	Akron Coating & Adhesives	1be1f1ce-3238-a8ed-e063-6294a90a5aed	2024-06-27		Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3C5ORO99TY	TRIPELENNAMINE	91-81-6	TRIPELENNAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2711712	tripelennamine HCl 1 % Topical Cream	PSN	12f72d74-018f-4bc6-acd4-175ca3af4c6d	3
2711712	tripelennamine hydrochloride 10 MG/ML Topical Cream	SCD	12f72d74-018f-4bc6-acd4-175ca3af4c6d	3
2711712	tripelennamine hydrochloride 1 % Topical Cream	SY	12f72d74-018f-4bc6-acd4-175ca3af4c6d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69993-151-01	69993015101	1 TUBE in 1 CARTON (69993-151-01) / 28 g in 1 TUBE	1 tube	2025-02-01	No	No	Current
69993-151-02	69993015102	3.25 g in 1 POUCH (69993-151-02)	3.25 g	2025-02-01	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PBZ ™ OTC Cream	Kingsway Pharmaceuticals dba NFI, LLC	2025-08-29	HUMAN OTC DRUG LABEL	3
PBZ ™ OTC Cream	IBR Packaging, LLC	2025-04-10	HUMAN OTC DRUG LABEL	1