FDA.reportPublic FDA data

Ice Cold Analgesic Gel

Product NDC
52000-013
Requested package NDC
52000-013-18
11-digit product format
520000013
Labeler code
52000
Product ID
52000-013_d882e2a1-eb18-30f1-e053-2a95a90aebdf
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Camphor
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-15
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52000-01352000-013-18IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52000-013-132025-07-29Ice Cold Anagelsic Gel
52000-013-142025-07-29Ice Cold Anagelsic Gel
52000-013-152025-07-29Ice Cold Anagelsic Gel
52000-013-162025-07-29Ice Cold Anagelsic Gel
52000-013-172025-07-29Ice Cold Anagelsic Gel
52000-013-182025-07-29Ice Cold Anagelsic Gel
52000-013-132022-02-21Ice Cold Anagelsic Gel
52000-013-142022-02-21Ice Cold Anagelsic Gel
52000-013-152022-02-21Ice Cold Anagelsic Gel
52000-013-162022-02-21Ice Cold Anagelsic Gel
52000-013-172022-02-21Ice Cold Anagelsic Gel
52000-013-182022-02-21Ice Cold Anagelsic Gel
52000-013-132020-01-31Ice Cold Anagelsic Gel
52000-013-142020-01-31Ice Cold Anagelsic Gel
52000-013-152020-01-31Ice Cold Anagelsic Gel
52000-013-162020-01-31Ice Cold Anagelsic Gel
52000-013-172020-01-31Ice Cold Anagelsic Gel
52000-013-182020-01-31Ice Cold Anagelsic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-013-13Ice Cold Analgesic Gel170 g in 1 BOTTLE, PLASTICGEL1704
52000-013-14Ice Cold Analgesic Gel227 g in 1 BOTTLE, PLASTICGEL2274
52000-013-15Ice Cold Analgesic Gel300 g in 1 BOTTLE, PLASTICGEL3004
52000-013-16Ice Cold Analgesic Gel500 g in 1 BOTTLE, PLASTICGEL5004
52000-013-17Ice Cold Analgesic Gel127 g in 1 TUBEGEL1274
52000-013-18Ice Cold Analgesic Gel170 g in 1 TUBEGEL1704

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-013ICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]4Legacy NDC, 6 package rows20241212_422bd4a3-f03f-496e-b44f-d51885678baa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043046camphor 0.5 % / menthol 1 % Topical GelPSN422bd4a3-f03f-496e-b44f-d51885678baa4
1043046camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical GelSCD422bd4a3-f03f-496e-b44f-d51885678baa4
1043046camphor 0.5 % / menthol 1 % Topical GelSY422bd4a3-f03f-496e-b44f-d51885678baa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-013-1852000001318170 g in 1 TUBE (52000-013-18) 170 g2022-02-140000-00-00NoNoCurrent