FDA.reportPublic FDA data

Blue Ice Topical Analgesic Gel

Product NDC
52862-901
11-digit product format
528620901
Labeler code
52862
Product ID
52862-901_397ce4f6-f5af-18f1-e063-6394a90ad7c5
Type
HUMAN OTC DRUG
Nonproprietary name
Ice Gel
Dosage form
GEL
Route
TOPICAL
Labeler
International Wholesale
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
CAMPHOR (SYNTHETIC); 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
Blue Ice Topical Analgesic Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).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
5TJD82A1ETInternal 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
1043046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
397cd306-078d-5b7d-e063-6294a90a8bbcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-901-01Blue Ice Topical Analgesic Gel227 g in 1 TUBEGEL2271

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 124 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
application number: M017
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
application number: M017
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVS20234356-5e80-b79e-e063-6294a90a2ee32024-10-04WarningsExact identifier
application number: M017
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC11a30ec9-ebc2-4a00-8a8d-431d0d973b372024-10-03WarningsExact identifier
application number: M017
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
application number: M017
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043046camphor 0.5 % / menthol 1 % Topical GelPSN397cd306-078d-5b7d-e063-6294a90a8bbc1
1043046camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical GelSCD397cd306-078d-5b7d-e063-6294a90a8bbc1
1043046camphor 0.5 % / menthol 1 % Topical GelSY397cd306-078d-5b7d-e063-6294a90a8bbc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52862-901-0152862090101227 g in 1 TUBE (52862-901-01) 227 g2024-01-01NoNoCurrent