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 52 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
application number: M016
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
application number: M016
Mustela Diaper Rash SprayableZINC OXIDEExpanscience Laboratories d/b/a Mustelad9a2aaf6-ab71-97a3-e053-2a95a90a34982024-12-02WarningsExact identifier
application number: M016
Mustela Stelatopia Intense Eczema Relief Skin ProtectantCOLLOIDAL OATMEALExpanscience Laboratories d/b/a Mustelae9ac358e-c9bd-7091-e053-2a95a90a46092024-12-02WarningsExact identifier
application number: M016
ZINC OXIDEZINC OXIDEVIVE HEALTH LLC284dbf6a-6fa2-742b-e063-6394a90afdfd2024-12-02WarningsExact identifier
application number: M016
Readyflush Protect Wipes Fragrance FreeDIMETHICONEMedline Industries, LP743d21bd-c40a-4415-ad97-0d8aa99a8af72024-12-02WarningsExact identifier
application number: M016
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact 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