BIOSAVIA External Analgesic Pain Relief

Product NDC: 84680-529
11-digit product format: 846800529
Labeler code: 84680
Product ID: 84680-529_20ba72da-a0c4-0f35-e063-6394a90af8e8
Type: HUMAN OTC DRUG
Nonproprietary name: CAPSAICIN
Dosage form: GEL
Route: TOPICAL
Labeler: BIOSAVIA USA, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-19
Substance: CAPSAICIN
Active strength: .25 mg/g
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: BIOSAVIA External Analgesic Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S07O44R1ZM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199870	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
814aa66b-7719-4a29-a84e-18290367e9c7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84680-529-00	BIOSAVIA External Analgesic Pain Relief	117.5 g in 1 BOTTLE	GEL	117.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84680-529	BIOSAVIA EXTERNAL ANALGESIC PAIN RELIEF (CAPSAICIN) GEL [BIOSAVIA USA, LLC]	1	Current NDC, 1 package rows	20240829_814aa66b-7719-4a29-a84e-18290367e9c7.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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUSCLE	MENTHOL	WATER-JEL TECHNOLOGIES	1af399af-07b0-4899-9bcc-1e244b63b1cf	2025-04-08	Warnings	Exact identifier application number: M017
Lidocaine with Menthol	LIDOCAINE HCL AND MENTHOL	Kareway Product, Inc.	9ee46a5b-d00c-4254-e053-2995a90aeb3a	2025-04-08	Warnings	Exact identifier application number: M017
Foster and Thrive Lidocaine Pain Relief Patch	LIDOCAINE 4%	Strategic Sourcing Services LLC	324802c9-e2c2-bf74-e063-6394a90a8697	2025-04-08	Warnings	Exact identifier application number: M017
OARS AND ALPS MUSCLE RECOVERY BALM	MENTHOL, METHYL SALICYLATE	Cosco International, Inc	8745802f-018d-4cf8-bbf3-3b04c8f54538	2025-04-08	Warnings	Exact identifier application number: M017
NOVUM APR	MENTHOL	NOVUM SOLUTIONS INC	1b869a1f-5787-4d03-a546-43a8217b2b2c	2025-04-07	Warnings	Exact identifier application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLING	MENTHOL	RENU LABORATORIES, LLC	31e4fa2c-3a98-d618-e063-6394a90aec1c	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	cc7cbf4a-8274-e463-e053-2995a90a51e0	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee018a-2c3c-3116-e053-2a95a90ac8d8	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee2b65-2759-0e62-e053-2a95a90a0378	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bdc7c7f3-ac98-8fe9-e053-2a95a90a2663	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bd4fdff1-9174-31c2-e053-2a95a90a749f	2025-04-07	Warnings	Exact identifier application number: M017
GREEN GUARD Topical Pain Relief	LIDOCAINE HCI	Ultra Distributors Inc	b6f0041c-47fc-0bcd-e053-2a95a90ab1f9	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebc1c6-93fb-efd6-e053-2995a90a25bb	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 4	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0e9ac7c-a840-2e05-e053-2a95a90a33f1	2025-04-07	Warnings	Exact identifier application number: M017
CBDMEDIC Active Sport Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec5f47-2f8e-0558-e053-2a95a90aa7ca	2025-04-07	Warnings	Exact identifier application number: M017
Hot Cold Medicated Patches	HOT COLD MEDICATED PATCHES	Henan Enokon Medical Instrument Co., Ltd.	159266a8-94fa-e2ff-e063-6394a90a9a77	2025-04-02	Warnings	Exact identifier application number: M017
Pain Relief Patch	PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592d29d-e275-a44d-e063-6294a90ab17d	2025-04-02	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	766b73f2-67bd-4d5c-805c-1057b3981ebf	2025-04-02	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Asclemed USA, Inc.	d4d556c1-b64b-4b8e-8e4b-4f40eda24250	2025-04-01	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	31ce185e-07b7-d837-e063-6394a90a1fb0	2025-04-01	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199870	capsaicin 0.025 % Topical Gel	PSN	814aa66b-7719-4a29-a84e-18290367e9c7	1
199870	capsaicin 0.00025 MG/MG Topical Gel	SCD	814aa66b-7719-4a29-a84e-18290367e9c7	1
199870	capsaicin 0.025 % Topical Gel	SY	814aa66b-7719-4a29-a84e-18290367e9c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84680-529-00	84680052900	117.5 g in 1 BOTTLE (84680-529-00)	117.5 g	2024-08-19	No	No	Current