Cool Comfort

Product NDC
71453-211
11-digit product format
714530211
Labeler code
71453
Product ID
71453-211_453a56c6-c855-bf95-e063-6394a90ac750
Type
HUMAN OTC DRUG
Nonproprietary name
ORGANIC WITCH HAZEL
Dosage form
SWAB
Route
TOPICAL
Labeler
Naticura Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-11-29
Substance
WITCH HAZEL
Active strength
60 g/100g
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
Cool Comfort
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL60 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1990878Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de14c19c-56b5-4727-9194-94e85425ca8aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71453-211-00Cool Comfort100 in 1 PACKAGESWAB1006
71453-211-00Cool Comfort2.9 g in 1 PACKETSWAB2.96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71453-211COOL COMFORT (ORGANIC WITCH HAZEL) SWAB [NATICURA INC]5Current NDC, Legacy NDC, 2 package rows20241211_de14c19c-56b5-4727-9194-94e85425ca8a.zip

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 7 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sosnowskis Magic Healing Multi actionCAMPHOR AND COLLOIDAL OATMEALHerstat (USA) Inc.38cd8f11-7264-a004-e063-6294a90a3a1b2026-07-03WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
application number: M016
Drs. Pharmacy Baby HealingZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY55a6981c-1b32-f448-e063-6294a90ac6d82026-07-02WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.558d239e-b0cf-c145-e063-6294a90a8a8b2026-07-01WarningsExact identifier
application number: M016
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
application number: M016
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.55833e0f-d184-16a2-e063-6394a90acfd32026-06-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5566bce3-fc49-5ef4-e063-6294a90abc7a2026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet PlumCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5568ada5-3ae6-3366-e063-6294a90a71192026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted CoconutCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55698d88-aae7-c46c-e063-6394a90ad0ac2026-06-29WarningsExact identifier
application number: M016
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M016
ORLASKIN HYDROGEL EYE MASKALLANTOINGuangzhou Yapheon Health Industry Co., Ltd.552d072b-396f-c88a-e063-6294a90aabcd2026-06-26WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP3c442890-733d-8175-e063-6294a90a8b1c2026-06-24WarningsExact identifier
application number: M016
MOROVANESTRIOLHONG KONG UNORDERED TRADING CO., LIMITED54fa4308-44a4-e9dd-e063-6394a90a0cd72026-06-24WarningsExact identifier
application number: M016
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsExact identifier
application number: M016
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
application number: M016
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
application number: M016
CLEAR ANTI ITCHPRAMOXINE HCL, ZINC ACETATE LOTIONH E B54f04056-d805-8c62-e063-6394a90ab7402026-06-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1990878witch hazel 60 % Medicated PadPSNde14c19c-56b5-4727-9194-94e85425ca8a6
1990878witch hazel 600 MG/ML Medicated PadSCDde14c19c-56b5-4727-9194-94e85425ca8a6
1990878witch hazel 60 % Medicated PadSYde14c19c-56b5-4727-9194-94e85425ca8a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71453-211-0071453021100100 PACKET in 1 PACKAGE (71453-211-00) / 2.9 g in 1 PACKET100 packet2017-11-290000-00-00NoNoCurrent