FDA.reportPublic FDA data

AER

Product NDC
50289-3250
11-digit product format
502893250
Labeler code
50289
Product ID
50289-3250_2baae3c5-a04e-c51e-e063-6394a90a81c3
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
SOLUTION
Route
RECTAL; TOPICAL
Labeler
Birchwood Laboratories LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
Substance
WITCH HAZEL
Active strength
500 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AER
Brand name suffix
Pre-moistened Witch Hazel Pad
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii101I4J0U34
Rxcui844379, 1247719

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50289-3250-1AERPre-moistened Witch Hazel Pad40 in 1 JARSOLUTION406
50289-3250-1AERPre-moistened Witch Hazel Pad2.8 mL in 1 APPLICATORSOLUTION2.86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50289-3250-1EA - Each50289-3250c05692d4-5d66-4fbc-aafa-1ed8ae419bed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U34AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Witch HazelACTIVE MOIETY101I4J0U34AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
WaterINACTIVE INGREDIENT059QF0KO0RAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50289-3250AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250115_1cca622f-0a6b-4f35-9355-34c249ee705e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247719A.E.R. 50 % Medicated PadPSN1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated PadPSN1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719witch hazel 500 MG/ML Medicated Pad [A.E.R. Witch Hazel]SBD1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 500 MG/ML Medicated PadSCD1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719A.E.R. 50 % Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719A.E.R. Witch Hazel 500 MG/ML Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated WipesSY1cca622f-0a6b-4f35-9355-34c249ee705e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50289-3250-15028932500140 APPLICATOR in 1 JAR (50289-3250-1) / 2.8 mL in 1 APPLICATOR40 applicator2018-06-280000-00-00NoNoCurrent