FDA.reportPublic FDA data

U ICE COLD

Product NDC
52000-045
11-digit product format
520000045
Labeler code
52000
Product ID
52000-045_0718e1be-e778-00f3-e063-6394a90a114e
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
UNIVERSAL DISTRIBUTION CENTER LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
CAMPHOR, (-)-; MENTHOL
Active strength
.5; 1 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
U ICE COLD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR, (-)-.5 g/100g
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213N3S8275Internal 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
2056456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
752ef0cd-f12a-3b9e-e053-2991aa0abeb1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-045-01U ICE COLD227 g in 1 TUBEOINTMENT2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-045U ICE COLD (MENTHOL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231008_752ef0cd-f12a-3b9e-e053-2991aa0abeb1.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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056456camphor 0.5 % / menthol 1 % Topical OintmentPSN752ef0cd-f12a-3b9e-e053-2991aa0abeb12
2056456camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical OintmentSCD752ef0cd-f12a-3b9e-e053-2991aa0abeb12
2056456camphor 0.5 % / menthol 1 % Topical OintmentSY752ef0cd-f12a-3b9e-e053-2991aa0abeb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-045-0152000004501227 g in 1 TUBE (52000-045-01) 227 g2018-08-010000-00-00NoNoCurrent