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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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