FDA.reportPublic FDA data

daily solutions Ice Blue

Product NDC
67385-708
11-digit product format
673850708
Labeler code
67385
Product ID
67385-708_18084a71-75ce-4e56-86dd-179edf5e0d69
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Unspecified Form
Dosage form
GEL
Route
TOPICAL
Labeler
Garcoa, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-31
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
20 mg/g
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
daily solutions Ice Blue
Brand name suffix
Analgesic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67385-708-01daily solutions Ice BlueAnalgesic227 g in 1 JARGEL2271
67385-708-02daily solutions Ice BlueAnalgesic454 g in 1 JARGEL4541

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 123 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal PAIN RELIEFLIDOCAINEUniversal Distribution Center LLCb132a4f2-1b1f-4e80-a183-f9add449065f2024-10-14WarningsExact identifier
application number: M017
Nervex Pain RelievingCAPSAICINVITA SCIENCES, LLCa39bba22-8c54-4252-9973-052dd2aaea362024-10-14WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENATURAL ESSENTIALS, INC.d07fdffd-bf7c-4950-9b2d-c06d54ef4c552024-10-14WarningsExact identifier
application number: M017
Walgreens CoolingLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYbaffb272-436c-4ad8-e053-2a95a90a56fb2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefMENTHOLWALGREEN COMPANYc8967fba-6c28-494b-e053-2995a90acbba2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFMeijer Distribution Inc18998e1c-1254-4d0c-93f1-26652c5ca0762024-10-14WarningsExact identifier
application number: M017
signature care itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATESafeway3eedcd9f-8312-4d14-a0fe-6b00a00d3e732024-10-13WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact identifier
application number: M017
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENatural Essentials, Inc.fc23b2e2-4abc-4119-b8bd-305b4327f1dd2024-10-09WarningsExact identifier
application number: M017
KERACAREMENTHOL 1%Avlon Industries, Inc.f72eec6d-1204-4e03-8aed-d5bcf8d3bbce2024-10-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e61
311502menthol 0.02 MG/MG Topical GelSCD4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e61
311502menthol 2 % Topical GelSY4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e61
311502menthol 2 % topical stickSY4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67385-708-0167385070801227 g in 1 JAR (67385-708-01) 227 g2017-05-31NoNoCurrent
67385-708-0267385070802454 g in 1 JAR (67385-708-02) 454 g2023-12-04NoNoCurrent