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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLAmazon.com Services LLCadb638ec-4a7c-42f2-b249-0ac53a8dd4b22026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact 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