FDA.reportPublic FDA data

QC Medicated Cooling

Product NDC
83324-311
Requested package NDC
83324-311-01
11-digit product format
833240311
Labeler code
83324
Product ID
83324-311_4656c53f-21e8-9318-e063-6394a90ab231
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
Chain Drug Marketing Association, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
Substance
WITCH HAZEL
Active strength
500 mg/1
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
QC Medicated Cooling
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/1

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
844379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24c49214-b333-fba4-e063-6394a90a1a70Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-311-01QC Medicated Cooling1 in 1 CARTONCLOTH16
83324-311-01QC Medicated Cooling100 in 1 JARCLOTH1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-311-01EA - Each83324-3110962f923-e790-49a2-9470-c198a286501712026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-311QC MEDICATED COOLING (WITCH HAZEL) CLOTH [CHAIN DRUG MARKETING ASSOCIATION, INC.]4Current NDC, 2 package rows20250417_24c49214-b333-fba4-e063-6394a90a1a70.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QC Medicated CoolingWITCH HAZELChain Drug Marketing Association, Inc.24c49214-b333-fba4-e063-6394a90a1a702025-12-19WarningsExact identifier
ndc (package): 83324-311-01
ndc (product): 83324-311
ndc11 (package): 83324031101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSN24c49214-b333-fba4-e063-6394a90a1a706
844379witch hazel 500 MG/ML Medicated PadSCD24c49214-b333-fba4-e063-6394a90a1a706
844379witch hazel 50 % Medicated PadSY24c49214-b333-fba4-e063-6394a90a1a706
844379witch hazel 50 % Medicated WipesSY24c49214-b333-fba4-e063-6394a90a1a706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-311-01833240311011 JAR in 1 CARTON (83324-311-01) / 100 CLOTH in 1 JAR1 jar2024-10-30NoNoCurrent