FDA.reportPublic FDA data

Analgesic Balm

Product NDC
57896-116
11-digit product format
578960116
Labeler code
57896
Product ID
57896-116_11586e2c-ea92-7cfc-e063-6294a90a7de7
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 10%, Methyl Salicylate 15%
Dosage form
CREAM
Route
TOPICAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-05
Substance
MENTHOL; METHYL SALICYLATE
Active strength
10; 15 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
Analgesic Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100g
METHYL SALICYLATE15 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311498Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab9bf09d-bc8c-6d17-e053-2995a90a6c36Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-116-012024-02-14C16284748780-11030e365-4ba2-111a-e063-dadaa90a10e2GERI-CARE Analgesic Balm
57896-116-012024-01-30C16284748780-11030e365-4ba2-111a-e063-dadaa90a10e2GERI-CARE Analgesic Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-116-03Analgesic Balm85 g in 1 TUBECREAM856
57896-116-03Analgesic Balm1 in 1 BOXCREAM16
57896-116-01Analgesic Balm28 g in 1 TUBECREAM282
57896-116-01Analgesic Balm1 in 1 BOXCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-116-01GM - Gram57896-116eb00359e-6779-4d5d-889f-faf01a0aef3a12022-03-09
57896-116-03GM - Gram57896-1168d140034-fadf-497b-b76d-6eaf558392dd12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-116ANALGESIC BALM (MENTHOL 10%, METHYL SALICYLATE 15%) CREAM [GERI-CARE PHARMACEUTICALS, CORP]5Current NDC, Legacy NDC, 2 package rows20241222_c8594e10-661f-6ff3-e053-2995a90ab4fc.zip
57896-116ANALGESIC BALM (MENTHOL 10%, METHYL SALICYLATE 15%) CREAM [GERI-CARE PHARMACEUTICALS, CORP]2Current NDC, Legacy NDC, 2 package rows20240215_ab9bf09d-bc8c-6d17-e053-2995a90a6c36.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNc8594e10-661f-6ff3-e053-2995a90ab4fc6
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDc8594e10-661f-6ff3-e053-2995a90ab4fc6
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYc8594e10-661f-6ff3-e053-2995a90ab4fc6
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYc8594e10-661f-6ff3-e053-2995a90ab4fc6
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNab9bf09d-bc8c-6d17-e053-2995a90a6c362
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDab9bf09d-bc8c-6d17-e053-2995a90a6c362
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYab9bf09d-bc8c-6d17-e053-2995a90a6c362
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYab9bf09d-bc8c-6d17-e053-2995a90a6c362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-116-01578960116011 TUBE in 1 BOX (57896-116-01) / 28 g in 1 TUBE1 tube2020-08-050000-00-00NoNoCurrent
57896-116-03578960116031 TUBE in 1 BOX (57896-116-03) / 85 g in 1 TUBE1 tube2021-08-020000-00-00NoNoCurrent