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
PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; GLYCERIN; PETROLATUM
Active strength
10; 2.5; 144; 150 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoidal Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
04JA59TNSJInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293649Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
374dc1c0-4243-b272-e063-6394a90a5a6bAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact identifier
application number: M015

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