FDA.reportPublic FDA data

ULTRA RELIEF

Product NDC
49283-578
11-digit product format
492830578
Labeler code
49283
Product ID
49283-578_48e9bcf4-0751-7b3f-e063-6294a90ac649
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
CHEMCO CORPORATION
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-15
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
6; 3 g/100g; g/100g
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
ULTRA RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL6 g/100g
CAMPHOR (SYNTHETIC)3 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
5TJD82A1ETInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48ea80cf-af54-ce5f-e063-6394a90ac493Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49283-578-04ULTRA RELIEF113 g in 1 BOTTLE, PUMPGEL1132

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 80 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49283-578-0449283057804113 g in 1 BOTTLE, PUMP (49283-578-04) 113 g2026-01-15NoNoCurrent