FDA.reportPublic FDA data

Valtrum Soothing Topical Analgesic

Product NDC
75849-300
11-digit product format
758490300
Labeler code
75849
Product ID
75849-300_b0617409-47b2-6e4c-e053-2995a90a721e
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Laboratorios Quantium LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-11-12
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
25 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75849-300-002022-01-28C16284748780-1ab0e2407-2fd2-f274-e053-dbdaa90a6471Valtrum Soothing Topical Analgesic Ointment
75849-300-002020-09-28C16284748780-1ab0e2407-2fd2-f274-e053-dbdaa90a6471Valtrum Soothing Topical Analgesic Ointment
75849-300-002020-09-27C16284748780-1ab0e2407-2fd2-f274-e053-dbdaa90a6471Valtrum Soothing Topical Analgesic Ointment
75849-300-002020-09-25C16284748780-1ab0e2407-2fd2-f274-e053-dbdaa90a6471Valtrum Soothing Topical Analgesic Ointment
75849-300-002020-07-22C16284748780-1ab0e2407-2fd2-f274-e053-dbdaa90a6471Valtrum Soothing Topical Analgesic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-300-00Valtrum Soothing Topical Analgesic90 g in 1 BOTTLEOINTMENT904
75849-300-00Valtrum Soothing Topical Analgesic1 in 1 CARTONOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
MENTHOLACTIVE MOIETYL7T10EIP3AVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
GLUCOSAMINEINACTIVE INGREDIENTN08U5BOQ1KVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
HARPAGOPHYTUM PROCUMBENS ROOTINACTIVE INGREDIENT1OYM338E89VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RVALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-300VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]4Legacy NDC, 2 package rows20200929_bf7d00d1-901a-47e4-ada7-2e647a42304c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721696camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % Topical OintmentPSNbf7d00d1-901a-47e4-ada7-2e647a42304c4
1721701Valtrum Soothing 2.5 % / 2.5 % / 10 % Topical OintmentPSNbf7d00d1-901a-47e4-ada7-2e647a42304c4
1721701camphor 0.025 MG/MG / menthol 0.025 MG/MG / methyl salicylate 0.1 MG/MG Topical Ointment [Valtrum Soothing]SBDbf7d00d1-901a-47e4-ada7-2e647a42304c4
1721696camphor 0.025 MG/MG / menthol 0.025 MG/MG / methyl salicylate 0.1 MG/MG Topical OintmentSCDbf7d00d1-901a-47e4-ada7-2e647a42304c4
1721696camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % Topical OintmentSYbf7d00d1-901a-47e4-ada7-2e647a42304c4
1721701Valtrum Soothing (camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % ) Topical OintmentSYbf7d00d1-901a-47e4-ada7-2e647a42304c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75849-300-00758490300001 BOTTLE in 1 CARTON (75849-300-00) > 90 g in 1 BOTTLE1 bottle2015-11-120000-00-00NoNoCurrent