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#

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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
application number: M017
Walgreens Burn PadBURN PADWalgreens3f8d7624-cf1e-1992-e063-6294a90a38062026-03-17Boxed warning, WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
application number: M017
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
application number: M017
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
application number: M017
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
application number: M017
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
application number: M017
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
application number: M017
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
application number: M017
Keeps Climax DelayLIDOCAINE HYDROCHLORIDECosco International, Inc.3bfd3173-2dac-40a9-aec3-982b1d47d8fa2026-03-12WarningsExact identifier
application number: M017
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
application number: M017
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
application number: M017
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
application number: M017
Lidocaine HCLLIDOCAINE HCLMatthias Therapeutics, LLC4cdb27b5-9178-0328-e063-6394a90a50b52026-03-12WarningsExact 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