FDA.reportPublic FDA data

HealthWise Ultra OTC Strength Pain Relief Cream

Product NDC
71101-070
11-digit product format
711010070
Labeler code
71101
Product ID
71101-070_36c3bbf9-a55a-4c0d-e063-6394a90a8a1a
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, and METHYL SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
40; 100; 300 mg/g; mg/g; 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
HealthWise Ultra OTC Strength Pain Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)40 mg/g
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE300 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283083Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36c3bbf9-a559-4c0d-e063-6394a90a8a1aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-070-01HealthWise Ultra OTC Strength Pain Relief Cream113 g in 1 TUBECREAM1131
71101-070-01HealthWise Ultra OTC Strength Pain Relief Cream1 in 1 CARTONCREAM11

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 140 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
application number: M017
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
application number: M017
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
application number: M017
DermaWound Wound Care Venous StasisBENZOCAINE HYDROCHLORIDEProgressive Doctors, LLC6221ba86-8b7f-48c8-8284-6950f9fc36b12023-12-15WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Humco Holding Group, Inc.a8be9e46-1616-40a9-e053-2a95a90ac3bc2023-12-15WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
application number: M017
Freds Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLDiscount Drug Mart8697b932-da5a-717e-e053-2a91aa0afcae2023-12-12WarningsExact identifier
application number: M017
CVS Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLCVS86972218-31fe-6942-e053-2991aa0a88502023-12-12WarningsExact identifier
application number: M017
Best Choice Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLvalue merchandisers869631f8-aa1e-8ea4-e053-2a91aa0a5c572023-12-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Weeks & Leo Co., Inc.0c5325e3-4796-856c-e063-6394a90a1f902023-12-12WarningsExact identifier
application number: M017
Westlake Anti-itchHYDROCORTISONEWestlake Pharma LLC0c53c982-3f23-a2d5-e063-6394a90acd552023-12-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN36c3bbf9-a559-4c0d-e063-6394a90a8a1a1
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD36c3bbf9-a559-4c0d-e063-6394a90a8a1a1
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY36c3bbf9-a559-4c0d-e063-6394a90a8a1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-070-01711010070011 TUBE in 1 CARTON (71101-070-01) / 113 g in 1 TUBE1 tube2025-06-01NoNoCurrent