FDA.reportPublic FDA data

Valtrum Topical Analgesic Roll On

Product NDC
75849-301
11-digit product format
758490301
Labeler code
75849
Product ID
75849-301_e0089b62-e19a-4ab7-a2f0-a8e9a70ff2e8
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)
Dosage form
GEL
Route
TOPICAL
Labeler
LABORATORIOS QUANTIUM LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
Substance
METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL)
Active strength
10; 3; 3 g/100g; g/100g; g/100g
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
Valtrum Topical Analgesic Roll On
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100g
MENTHOL, UNSPECIFIED FORM3 g/100g
CAMPHOR (NATURAL)3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2123377Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28167e2a-9afb-44e7-90c7-9577df9504b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-11-2828167e2a-9afb-44e7-90c7-9577df9504b6
2023-01-3028167e2a-9afb-44e7-90c7-9577df9504b6
2021-08-2528167e2a-9afb-44e7-90c7-9577df9504b6
2021-01-2928167e2a-9afb-44e7-90c7-9577df9504b6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-301-03Valtrum Topical Analgesic Roll On90 g in 1 TUBE, WITH APPLICATORGEL903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-301VALTRUM TOPICAL ANALGESIC ROLL ON (SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)) GEL [LABORATORIOS QUANTIUM LLC]3Current NDC, Legacy NDC, 1 package rows20231129_28167e2a-9afb-44e7-90c7-9577df9504b6.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 33 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCLValu Merchandisers Company87ee2b4f-d640-4cec-9f48-1d8aa54434e92026-02-16Warnings, Adverse reactionsExact identifier
application number: M017
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
application number: M017
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
application number: M017
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
application number: M017
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
application number: M017
Walgreens Pain Relieving Lidocaine PatchLIDOCAINEWalgreen Co.41c4e9fe-e407-b22a-e063-6394a90a4b272026-02-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123377camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical GelPSN28167e2a-9afb-44e7-90c7-9577df9504b63
2123377camphor 0.03 MG/MG / menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Topical GelSCD28167e2a-9afb-44e7-90c7-9577df9504b63
2123377camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical GelSY28167e2a-9afb-44e7-90c7-9577df9504b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75849-301-037584903010390 g in 1 TUBE, WITH APPLICATOR (75849-301-03) 90 g2019-03-010000-00-00NoNoCurrent