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 57 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUMWHITE PETROLATUMVIVE HEALTH LLC24ae3875-1c86-c7ba-e063-6394a90a67292024-10-17WarningsExact identifier
application number: M016
Meijer Skin Relieving MoisturizingDIMETHICONEMEIJER DISTRIBUTION, INC8e5be6b3-87e7-d958-e053-2a95a90a69612024-10-16WarningsExact identifier
application number: M016
GenRx Daily Defense Skin RepairingDIMETHICONEPureTek Corporation7d2827fd-b40f-454b-bb60-54d77823b18c2024-10-16WarningsExact identifier
application number: M016
Equate Daily Moisturizing Dimethicone Skin ProtectantDIMETHICONEWalmart Stores Inc.8fda01f7-a52a-4a63-98ac-b32cb47947f32024-10-16WarningsExact identifier
application number: M016
Hill Country EssentialsDIMETHICONEH.E.Bc51d8647-8af6-473a-b989-dfa6bfdc368d2024-10-15WarningsExact identifier
application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTEDWHITE PETROLEUMUniversal Distribution Center LLC649e571f-0cd6-41e4-b31f-c818f94fb01d2024-10-15WarningsExact identifier
application number: M016
WALGREENS ECZEMACOLLOIDAL OATMEALWALGREEN COMPANYfc502963-4cb6-5ce5-e053-6394a90a58c32024-10-14WarningsExact identifier
application number: M016
Target Up and Up Daily MoisturizingDIMETHICONETARGET CORPORATIONf118e0eb-1e66-50ab-e053-2995a90a2cb92024-10-14WarningsExact identifier
application number: M016
Target Up and Up Petroleum JellyWHITE PETROLATUMTARGET CORPORATIONbaeaf660-ac4f-1ebc-e053-2995a90ac0c12024-10-14WarningsExact identifier
application number: M016
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
application number: M016
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
application number: M016
Attitude Diaper Cream Zinc UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)00283894-ddc6-0faa-e063-6394a90ae47c2024-10-02WarningsExact identifier
application number: M016
DermacinRx Zinc Oxide Skin HealingZINC OXIDEPureTek Corporation541b8da8-f0c1-4f57-94a7-193084d9a6112024-10-02WarningsExact identifier
application number: M016
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
application number: M016
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
application number: M016
Barrier Build Skin Protectant CreamCOLLOIDAL OATMEALILIA, Inc.231d41b8-2a56-6eb8-e063-6394a90ac64f2024-09-27WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.229ee3a7-4129-7b59-e063-6394a90a6f402024-09-23WarningsExact 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