FDA.reportPublic FDA data

Arctic Ice Analgesic Gel

Product NDC
51328-2050
11-digit product format
513282050
Labeler code
51328
Product ID
51328-2050_7512601b-f94d-0076-e053-2991aa0a9ca8
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
ROYAL EXPORTS
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-09-21
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
2 g/227g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51328-2050IInactivated by FDA2026-07-31
excluded packagepackage51328-205051328-2050-1IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymethazoline HCLOXYMETHAZOLINE HCLPreferred Pharmaceuticals Inc.cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c42026-07-29WarningsExact identifier
Pi Yuan ChinNAPHAZOLINE HYDROCHLORIDEInternational Nature Nutraceuticalse7aedab9-da4c-4494-a896-1e6ed2a956fe2025-12-27WarningsExact identifier
Childrens Multi-symptom Cold DaytimeDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.1768677d-96ec-f9f7-e063-6394a90a4ef42025-11-21WarningsExact identifier
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162025-09-17WarningsExact identifier
TussinGUAIFENESINStrategic Sourcing Services188f3c82-b4bc-42a5-8068-c2fa0c2ac3442025-01-08WarningsExact identifier
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
QCH Adult Tussin DM 542DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17caffa4-a264-7f3e-e063-6394a90ac4192024-05-08WarningsExact identifier
QCH Adult Tussin DM Sugar free 545DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17cb91f0-32ec-9e0f-e063-6394a90a05092024-05-08WarningsExact identifier
QCH Adult Tussin 541GUAIFENESINChain Drug Marketing Association Inc.b487f4af-ad0c-4f18-9a6b-7fd386b3f46c2024-05-02WarningsExact identifier
QCH Maximum Strength Mucus Relief DM 628DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.a2795bf5-34c6-4de6-b9e5-53a23d18e3572024-04-26WarningsExact identifier
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services, Inc.07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e32024-04-17WarningsExact identifier
Quality Choice Dye Free Cherry Childrens Allergy ReliefDIPHENHYDRAMINE HCLChain Drug Marketing Association Inc.302ca7b5-f65c-4187-bbd6-f482be6e63c12024-03-18WarningsExact identifier
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992019-05-21WarningsExact identifier
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2019-05-15WarningsExact identifier
Discount Drug Mart Value Vapor SteamCAMPHOR (SYNTHETIC)Drug Mart87230c40-ea77-0f3a-e053-2991aa0ae7842019-04-22WarningsExact identifier
Best Choice Vapor SteamCAMPHOR (SYNTHETIC)Valu merchandiser86bb3a80-c675-d478-e053-2a91aa0a8c272019-04-17WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this prduct do not use more than directed do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur use of this container by more than one person may spread infection

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51328-2050-12021-01-29C16284748780-1ba0f9c33-3024-a910-e053-dadaa90a0b85751296e9-2f35-aa86-e053-2991aa0a54a4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51328-2050-1Arctic Ice Analgesic Gel227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51328-2050ARCTIC ICE ANALGESIC GEL (MENTHOL) GEL [ROYAL EXPORTS]1Legacy NDC, 1 package rows20190330_751296e9-2f35-aa86-e053-2991aa0a54a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039043menthol 1 % Topical GelPSN751296e9-2f35-aa86-e053-2991aa0a54a41
1039043menthol 0.01 MG/MG Topical GelSCD751296e9-2f35-aa86-e053-2991aa0a54a41
1039043menthol 1 % Topical GelSY751296e9-2f35-aa86-e053-2991aa0a54a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51328-2050-151328205001227 g in 1 JAR227 gHistorical