FDA.reportPublic FDA data

Nuvira

Product NDC
83295-3313
11-digit product format
832953313
Labeler code
83295
Product ID
83295-3313_1fcf5297-ce20-1bd9-e063-6294a90afc28
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10%
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Strand Health Group
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-29
Substance
METHYL NICOTINATE; METHYL SALICYLATE; CAPSAICIN; MENTHOL
Active strength
.0025; .1; .00025; .1 g/g; g/g; g/g; g/g
Pharmacologic classes
Nicotinic Acid [EPC], Nicotinic Acids [CS]
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
Nuvira
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL NICOTINATE.0025 g/g
METHYL SALICYLATE.1 g/g
CAPSAICIN.00025 g/g
MENTHOL.1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7B1AVU9DJNInternal UNII lookup
LAV5U5022YInternal UNII lookup
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2640874Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff448183-03cf-df2d-e053-6394a90a77f0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83295-3313-1Nuvira5 in 1 POUCHPATCH53
83295-3313-1Nuvira6 in 1 BOXPATCH63
83295-3313-5Nuvira8.5 g in 1 PATCHPATCH8.53
83295-3313-5Nuvira5 in 1 POUCHPATCH53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83295-3313-1EA - Each83295-3313b6c7ce3b-5cee-4800-9f41-cad90ab6638d12023-09-05
83295-3313-5EA - Each83295-3313b40f4116-fdeb-44b9-ba62-b319e642fa2b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83295-3313NUVIRA (CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%) PATCH [STRAND HEALTH GROUP]3Current NDC, 4 package rows20240817_ff448183-03cf-df2d-e053-6394a90a77f0.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 83 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3758d625-010f-7441-e063-6394a90a066d2025-07-29WarningsExact identifier
application number: M017
Cold Therapy Roll onCOLD THERAPY ROLL ONAllegiant Health36463acb-7c28-416f-a45f-a93f0be5692b2025-07-29WarningsExact identifier
application number: M017
ProCure Anti ItchCAMPHOR 0.5%Twin Med LLC3afe387c-ef42-215d-e063-6394a90a41b52025-07-28WarningsExact identifier
application number: M017
lidocaine pain relief patchesLIDOCAINEChangsha Maocheng Trading Co., Ltd3afeead3-4f5c-4711-e063-6294a90aacca2025-07-28WarningsExact identifier
application number: M017
SYNC ICESYNC RELIEF ICEiON Pharma, LLC38ce98ce-a7bf-8041-e063-6394a90ae7302025-07-28WarningsExact identifier
application number: M017
SYNC PROSYNC RELIEF PRO CREAMiON Pharma, LLC3a3e91d6-732b-dca9-e063-6394a90a06d42025-07-28WarningsExact identifier
application number: M017
Careland Pain ReliefMETHYL SALICYLATE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.83f36771-1033-4fd0-a0e6-82c1dcfedeee2025-07-28WarningsExact identifier
application number: M017
Rite Aid anti-itchHYDROCORTISONERite Aid Corporation2a232dd1-9071-4c55-a7f7-19d8404b99a62025-07-28WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONERITE AID CORPORATION05598255-3e7a-46a5-ae7e-dcfcb616d59d2025-07-28WarningsExact identifier
application number: M017
Inked InspiredLIDOCAINE HCLProdigy Media Inc54fb2860-7e63-4598-953a-170226e613e92025-07-28WarningsExact identifier
application number: M017
Ujhay Hydrocortisone Ointment.UJHAY HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3af59276-8e6a-0603-e063-6394a90a1f9b2025-07-27WarningsExact identifier
application number: M017
SANA SANA Menthol External AnalgesicMENTHOLAlquimia Najulam S de RL de CV8b7edd51-e08a-4e01-9df0-8305ce17b4182025-07-25WarningsExact identifier
application number: M017
Hydrocortisone Intensive Healing FormulaHYDROCORTISONETARGET Corporation682b737f-e453-4079-bf31-47a9485c78972025-07-25WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPierson Laboratories, Inc.8372e7c1-f145-4bc5-85ab-cf831abe70ce2025-07-24WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPharma Nobis, LLCe42fa1c6-d804-630f-e053-2995a90add6b2025-07-24WarningsExact identifier
application number: M017
Cannarelief 2000mgMENTHOLEarthmed LLC01f810de-52ba-8beb-e063-6394a90a61c02025-07-24WarningsExact identifier
application number: M017
CHING WAN HUNG SOOTHING HERBAL BALMMENTHOLTIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.ffadc904-8e9d-4cb8-815a-d583bbdb3f0b2025-07-24WarningsExact identifier
application number: M017
PT Elite Premium Pain ReliefCAPSAICIN, MENTHOLPT ELITE PRODUCTS LLCad251821-4c58-425d-bdcb-8dd9bd41b7132025-07-23WarningsExact identifier
application number: M017
Whipped Butter SPF 50ZINC OXIDEBloomeffects, Inc374b62d8-e012-591f-e063-6294a90aef932025-07-23WarningsExact identifier
application number: M017
Game On XtremeMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.5a1b6192-d537-42b3-add8-22c63e7c986c2025-07-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640874capsaicin 0.025 % / menthol 10 % / methyl salicylate 10 % / methylnicotinate 0.25 % Medicated PatchPSNff448183-03cf-df2d-e053-6394a90a77f03
2640874capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.1 MG/MG / methylnicotinate 0.0025 MG/MG Medicated PatchSCDff448183-03cf-df2d-e053-6394a90a77f03
2640874capsaicin 0.025 % / menthol 10 % / methyl salicylate 10 % / methylnicotinate 0.25 % Medicated PatchSYff448183-03cf-df2d-e053-6394a90a77f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83295-3313-1832953313016 POUCH in 1 BOX (83295-3313-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH6 pouch2023-06-29NoNoCurrent
83295-3313-5832953313055 PATCH in 1 POUCH (83295-3313-5) / 8.5 g in 1 PATCH5 patch2023-06-29NoNoCurrent