MegaBabe Butt Stuff Hemorrhoidal

Product NDC
84000-502
11-digit product format
840000502
Labeler code
84000
Product ID
84000-502_1aad3a81-c4c1-d1d6-e063-6394a90a7cb8
Type
HUMAN OTC DRUG
Nonproprietary name
COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
MEGABABE, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-06
Substance
COCOA BUTTER; GLYCERIN; LIDOCAINE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
125; 250; 50; 125; 2.5 mg/g; mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MegaBabe Butt Stuff Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER125 mg/g
GLYCERIN250 mg/g
LIDOCAINE50 mg/g
PETROLATUM125 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii512OYT1CRR, PDC6A3C0OX, 98PI200987, 4T6H12BN9U, 04JA59TNSJ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84000-502-00MegaBabe Butt Stuff Hemorrhoidal1 in 1 BOXOINTMENT11
84000-502-00MegaBabe Butt Stuff Hemorrhoidal35 g in 1 TUBEOINTMENT351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84000-502MEGABABE BUTT STUFF HEMORRHOIDAL (COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [MEGABABE, LLC]1Current NDC, 2 package rows20240613_01c156ff-69f9-4d5e-a9ea-abbc52d4afff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84000-502-00840000502001 TUBE in 1 BOX (84000-502-00) / 35 g in 1 TUBE1 tube2024-06-06NoNoCurrent