Hemorrhoid Master

Product NDC
72654-002
11-digit product format
726540002
Labeler code
72654
Product ID
72654-002_4a6d12df-28b8-3db3-e063-6294a90ac4d8
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, PHENYLEPHRINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ebanel Laboratories, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
LIDOCAINE; PHENYLEPHRINE
Active strength
40; 2.5 mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoid Master
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
PHENYLEPHRINE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 1WS297W6MV
Rxcui2673304

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
72654-002-01Hemorrhoid Master45 g in 1 TUBEOINTMENT455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72654-002HEMORRHOID MASTER (LIDOCAINE, PHENYLEPHRINE) OINTMENT [EBANEL LABORATORIES, INC]4Current NDC, Legacy NDC, 1 package rows20231227_41292d65-dabe-4bc3-872f-34a3912aa342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentPSN41292d65-dabe-4bc3-872f-34a3912aa3425
2673304lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD41292d65-dabe-4bc3-872f-34a3912aa3425
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentSY41292d65-dabe-4bc3-872f-34a3912aa3425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72654-002-017265400020145 g in 1 TUBE (72654-002-01) 45 g2019-11-010000-00-00NoNoCurrent