Hemorrhoidal Cream with Lidocaine

Product NDC
69396-181
11-digit product format
693960181
Labeler code
69396
Product ID
69396-181_4f1ef997-92ad-842f-e063-6294a90aab3f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerol, Phenylephine, Pramoxine, Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals Usa Llc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-10
Substance
GLYCERIN; LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE; WHITE PETROLATUM
Active strength
14.4; 5; .25; 15 g/100g; g/100g; g/100g; g/100g
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoidal Cream with Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN14.4 g/100g
LIDOCAINE5 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g
WHITE PETROLATUM15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 98PI200987, 04JA59TNSJ, B6E5W8RQJ4
Rxcui2642220

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-181-01Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-01Hemorrhoidal Cream with Lidocaine1 in 1 BOXCREAM11
69396-181-03Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-03Hemorrhoidal Cream with Lidocaine3 in 1 BOXCREAM31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamPSN4f1ef866-c4af-989b-e063-6294a90a148e1
2642220glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD4f1ef866-c4af-989b-e063-6294a90a148e1
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamSY4f1ef866-c4af-989b-e063-6294a90a148e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-181-01693960181011 TUBE in 1 BOX (69396-181-01) / 28 g in 1 TUBE1 tube2026-04-10NoNoCurrent
69396-181-03693960181033 TUBE in 1 BOX (69396-181-03) / 28 g in 1 TUBE3 tube2026-04-10NoNoCurrent