FDA.reportPublic FDA data

Ultra Balm

Product NDC
57598-888
11-digit product format
575980888
Labeler code
57598
Product ID
57598-888_46879b8b-9d05-4457-99ad-ddd77d90ceb7
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Methyl Salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ling Nam Medicine Factory (H.K.) Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-01
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
140; 232 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57598-88857598-888-25DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
Ultra Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM140 mg/g
METHYL SALICYLATE232 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1433200Internal RxNorm lookup
1433205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de997baf-aa04-474e-b912-3fc67e720d0bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57598-888-07Ultra Balm19.8 g in 1 JAROINTMENT19.89
57598-888-07Ultra Balm1 in 1 CARTONOINTMENT19
57598-888-23Ultra Balm65.1 g in 1 JAROINTMENT65.19
57598-888-23Ultra Balm1 in 1 CARTONOINTMENT19
57598-888-88Ultra Balm65.1 g in 1 JAROINTMENT65.19
57598-888-88Ultra Balm1 in 1 CARTONOINTMENT19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
Methyl SalicylateACTIVE INGREDIENTLAV5U5022YULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
MentholACTIVE MOIETYL7T10EIP3AULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
LanolinINACTIVE INGREDIENT7EV65EAW6HULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1
Thyme OilINACTIVE INGREDIENT2UK410MY6BULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57598-888ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]9Current NDC, Legacy NDC, 6 package rows20240724_de997baf-aa04-474e-b912-3fc67e720d0b.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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC56b8d0cc-2f35-7d38-e063-6294a90ad06d2026-07-16WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company56b93c89-295b-f33a-e063-6294a90a5fe42026-07-16WarningsExact identifier
application number: M017
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsExact identifier
application number: M017
Medi-First Muscle Rub CreamMENTHOL, METHYL SALICYLATEUnifirst First Aid Corporation56a6b8b2-7ab0-9854-e063-6294a90ab5ba2026-07-15WarningsExact identifier
application number: M017
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsExact identifier
application number: M017
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
application number: M017
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsExact identifier
application number: M017
ENOKON PAIN RELIEF Spray.PAIN RELIEF SPRAY.Henan Enokon Medical Instrument Co., Ltd.5675ec21-b947-2206-e063-6294a90aa5092026-07-12WarningsExact identifier
application number: M017
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
application number: M017
Penetral Roll-onCAPSAICIN 0.025%PureTek Corporation56204c03-8b15-a8b5-e063-6394a90a81892026-07-10WarningsExact identifier
application number: M017
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
application number: M017
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsExact identifier
application number: M017
CHEONG KUN PAIN RELIEVINGCAMPHORCHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED557d5cb3-2a05-4f45-e063-6394a90a9b122026-07-10WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
application number: M017
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
application number: M017
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
application number: M017
Lidocaine creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
application number: M017
Nupharmisto 4% Lidocaine Numbing creamLIDOCAINE 4%EveryMarket Inc5615e49d-e03b-f915-e063-6294a90a17862026-07-08WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
application number: M017
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433205LING NAM ULTRA BALM 14 % / 23.2 % Topical OintmentPSNde997baf-aa04-474e-b912-3fc67e720d0b9
1433200menthol 14 % / methyl salicylate 23.2 % Topical OintmentPSNde997baf-aa04-474e-b912-3fc67e720d0b9
1433205menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical Ointment [Ling Nam Ultra Balm]SBDde997baf-aa04-474e-b912-3fc67e720d0b9
1433200menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical OintmentSCDde997baf-aa04-474e-b912-3fc67e720d0b9
1433205Ling Nam Ultra Balm (menthol 14 % / methyl salicylate 23.2 % ) Topical OintmentSYde997baf-aa04-474e-b912-3fc67e720d0b9
1433200menthol 14 % / methyl salicylate 23.2 % Topical OintmentSYde997baf-aa04-474e-b912-3fc67e720d0b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57598-888-07575980888071 JAR in 1 CARTON (57598-888-07) / 19.8 g in 1 JAR1 jar2013-08-010000-00-00NoNoCurrent
57598-888-23575980888231 JAR in 1 CARTON (57598-888-23) / 65.1 g in 1 JAR1 jar2017-09-190000-00-00NoNoCurrent
57598-888-88575980888881 JAR in 1 CARTON (57598-888-88) / 65.1 g in 1 JAR1 jar2022-01-070000-00-00NoNoCurrent