FDA.reportPublic FDA data

COLD AND HOT MEDICATED LARGE

Product NDC
52000-421
11-digit product format
520000421
Labeler code
52000
Product ID
52000-421_6e490a04-d32f-4dec-9ced-ab55fae6efb1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-25
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.05 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
COLD AND HOT MEDICATED LARGE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.05 g/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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6780230-aa96-4055-b054-be41358568b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-421-41COLD AND HOT MEDICATED LARGE19 g in 1 PATCHPATCH197
52000-421-41COLD AND HOT MEDICATED LARGE1 in 1 POUCHPATCH17
52000-421-42COLD AND HOT MEDICATED LARGE1 in 1 POUCHPATCH17
52000-421-42COLD AND HOT MEDICATED LARGE24 in 1 BOXPATCH247

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 61 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
application number: M017
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCb0edd9d9-951f-d3dd-e053-2995a90a8d5a2025-11-21WarningsExact identifier
application number: M017
Up upLIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHESTarget Corporation44121d40-86e1-0df6-e063-6294a90aedaf2025-11-20WarningsExact identifier
application number: M017
Up upPAIN RELIEF ADVANCED HYDROGEL PATCHESTarget Corporation44128b70-3172-ee37-e063-6294a90a705f2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INCff073e47-3107-e17e-e053-6294a90a58fa2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF ROLL-ON 3OZ934d4638-b47b-187d-e053-2995a90ae69d2025-11-20WarningsExact identifier
application number: M017
FOOT PAIN RELIEF ROLL-ONLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd43edcea0-ab04-f368-e063-6294a90a817a2025-11-19WarningsExact identifier
application number: M017
Absolut Skin Corticosoothe Anti-ItchHYDROCORTISONEAbsolut Skin Incorporateddeb52218-9176-4aaa-a22f-b66dada6690f2025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited43f3d189-f6b7-02ed-e063-6394a90afd732025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2ZLIDOCAINEInterMed Laboratories Private Limited43f3e288-e828-8130-e063-6394a90a6d442025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
application number: M017
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
application number: M017
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
application number: M017
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNd6780230-aa96-4055-b054-be41358568b67
420222menthol 0.05 MG/MG Medicated PatchSCDd6780230-aa96-4055-b054-be41358568b67
420222menthol 5 % Medicated PatchSYd6780230-aa96-4055-b054-be41358568b67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-421-41520000421411 PATCH in 1 POUCH (52000-421-41) / 19 g in 1 PATCH1 patch2024-11-25NoNoCurrent
52000-421-425200004214224 POUCH in 1 BOX (52000-421-42) / 1 PATCH in 1 POUCH / 19 g in 1 PATCH24 pouch2024-11-25NoNoCurrent