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 100 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
application number: M017
Pain Reliveing PatchLIDOCAINE 4%simple diagnostics02ed0b27-bba9-ec0c-e063-6294a90a014d2025-02-07WarningsExact identifier
application number: M017
FlexDermal Pain Relieving Roll-OnMENTHOLSOLVADERM LLCd4d8050e-0761-4491-8635-39c806701eb52025-02-06WarningsExact identifier
application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
application number: M017
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP2d685602-5cd6-3b36-e063-6394a90a3c5d2025-02-05WarningsExact identifier
application number: M017
LidocoreLIDOCAINEiON Pharma, LLC204c3e50-1ac8-f442-e063-6294a90ae7b52025-02-05WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact 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