FDA.reportPublic FDA data

Hemorrhoidal Pain Relief

Product NDC
13709-335
11-digit product format
137090335
Labeler code
13709
Product ID
13709-335_3f904257-3af2-2c97-e063-6294a90aecae
Type
HUMAN OTC DRUG
Nonproprietary name
Hemorrhoidal Pain Relief Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [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
Hemorrhoidal Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN144 mg/g
PETROLATUM150 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
Rxcui1293649

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-335-01Hemorrhoidal Pain Relief1 in 1 CARTONCREAM12
13709-335-01Hemorrhoidal Pain Relief51 g in 1 TUBECREAM512

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN374dc1c0-4243-b272-e063-6394a90a5a6b2
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD374dc1c0-4243-b272-e063-6394a90a5a6b2
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY374dc1c0-4243-b272-e063-6394a90a5a6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-335-01137090335011 TUBE in 1 CARTON (13709-335-01) / 51 g in 1 TUBE1 tube2025-06-11NoNoCurrent