FDA.reportPublic FDA data

Extra Strength Balm

Product NDC
69204-030
11-digit product format
692040030
Labeler code
69204
Product ID
69204-030_498a5e2a-4de1-561c-e063-6394a90ac05c
Type
HUMAN OTC DRUG
Nonproprietary name
Capsicum, Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NATURES FORMULAE HEALTH PRODUCTS LTD.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
CAPSICUM; MENTHOL
Active strength
5; 2.5 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Extra Strength Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM5 g/100g
MENTHOL2.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00UK7646FGInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2735141Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
498a5e2a-4de0-561c-e063-6394a90ac05cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-030-01Extra Strength Balm1 in 1 CARTONOINTMENT11
69204-030-01Extra Strength Balm25 g in 1 JAROINTMENT251

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 34 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
application number: M017
NICOVITO HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4a5e24fa-959e-79b4-e063-6294a90a8f682026-02-09WarningsExact identifier
application number: M017
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA CORP4303fd30-0d35-3671-e063-6394a90a2aee2026-02-09WarningsExact identifier
application number: M017
Pain Relief LidocaineLIDOCAINEKroger Company4098756e-3d9f-317a-e063-6394a90af04c2026-02-09WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
application number: M017
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINEEbanel Laboratories, Inc41292d65-dabe-4bc3-872f-34a3912aa3422026-02-09WarningsExact identifier
application number: M017
DERMFREE NEUROPATHYARNICA MONTANA 1X HPUS 7% NEUROPATHYJiangxi Yudexi Pharmaceutical Co., LTD4a5c232d-5d29-2504-e063-6394a90ac9de2026-02-08WarningsExact identifier
application number: M017
ASSIELF NUMBING Topical AnorectalLIDOCAINEShenzhen Yuanbang International Logistics Co., Ltd4a5cb477-57ef-2a1d-e063-6394a90ac9ed2026-02-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieve Gel-PatchPAIN RELIEVE GEL-PATCHHenan Kangdi Medical Devices Co., Ltd1e31b950-e990-e255-e063-6394a90a7d232026-02-07WarningsExact identifier
application number: M017
Herbal Knee PatchHERBAL KNEE PATCHHenan Kangdi Medical Devices Co., Ltd2a009059-b515-8214-e063-6294a90a4ed32026-02-07WarningsExact identifier
application number: M017
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
application number: M017
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEShenzhen Wankelai E-commerce Co., Ltd.4a22562b-601e-97d7-e063-6394a90a5bca2026-02-06WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Sportpharm LLC1dd022b9-88ae-4737-88cc-fdb0ce0a83a32026-02-06WarningsExact identifier
application number: M017
Camphor plus Lidocaine Pain ReliefCAMPHOR, LIDOCAINEVeridian Healthcare4a2b73a8-c10c-85f9-e063-6294a90ac52c2026-02-06WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLRetail Business Services, LLC073c72fe-3171-4a4f-913a-d1b9630a1af32026-02-06Warnings, Adverse reactionsExact identifier
application number: M017
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735141capsicum extract 5 % / menthol 2.5 % Topical OintmentPSN498a5e2a-4de0-561c-e063-6394a90ac05c1
2735141Capsicum extract 0.05 MG/MG / menthol 0.025 MG/MG Topical OintmentSCD498a5e2a-4de0-561c-e063-6394a90ac05c1
2735141capsicum extract 5 % / menthol 2.5 % Topical OintmentSY498a5e2a-4de0-561c-e063-6394a90ac05c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69204-030-01692040030011 JAR in 1 CARTON (69204-030-01) / 25 g in 1 JAR1 jar2026-01-01NoNoCurrent