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 122 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
application number: M017
Universal PAIN RELIEFLIDOCAINEUniversal Distribution Center LLCb132a4f2-1b1f-4e80-a183-f9add449065f2024-10-14WarningsExact identifier
application number: M017
Nervex Pain RelievingCAPSAICINVITA SCIENCES, LLCa39bba22-8c54-4252-9973-052dd2aaea362024-10-14WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENATURAL ESSENTIALS, INC.d07fdffd-bf7c-4950-9b2d-c06d54ef4c552024-10-14WarningsExact identifier
application number: M017
Walgreens CoolingLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYbaffb272-436c-4ad8-e053-2a95a90a56fb2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefMENTHOLWALGREEN COMPANYc8967fba-6c28-494b-e053-2995a90acbba2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFMeijer Distribution Inc18998e1c-1254-4d0c-93f1-26652c5ca0762024-10-14WarningsExact identifier
application number: M017
signature care itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATESafeway3eedcd9f-8312-4d14-a0fe-6b00a00d3e732024-10-13WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact identifier
application number: M017
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact 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