FDA.reportPublic FDA data

Hemorrhoidal cocoa butter

Product NDC
13709-323
11-digit product format
137090323
Labeler code
13709
Product ID
13709-323_2beb0548-764d-eb34-e063-6294a90a64d9
Type
HUMAN OTC DRUG
Nonproprietary name
Hemorrhoidal
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
NeilMed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-24
Substance
PHENYLEPHRINE HYDROCHLORIDE; COCOA BUTTER
Active strength
2.5; 884.4 mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct13709-323UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13709-32313709-323-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 cocoa butter
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
COCOA BUTTER884.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
512OYT1CRRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03b159b0-b960-b38d-e063-6394a90a9462Available 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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-323-01Hemorrhoidal cocoa butter6 in 1 BLISTER PACKSUPPOSITORY62
13709-323-01Hemorrhoidal cocoa butter4 in 1 CARTONSUPPOSITORY42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-323HEMORRHOIDAL COCOA BUTTER (HEMORRHOIDAL) SUPPOSITORY [NEILMED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250119_03b159b0-b960-b38d-e063-6394a90a9462.zip

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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
application number: M015
Hemorrhoidal cooling gelPHENYLEPHRINE HCL, WITCH HAZELWALGREENS03bbe258-e00d-13cc-e063-6394a90ae3452023-12-05WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
application number: M015
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
application number: M015
Bloop Fissure Healing Anorectal TopicalLIDOCAINEThree Nations Corp0b645092-ebc4-e4bb-e063-6294a90ad4cf2023-11-30WarningsExact identifier
application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEFLIDOCAINEALPHA PLANTS INC79fa4b89-382f-45fa-a792-90a9fe5bf5732023-11-11WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Butt Eze BenzocaineBENZOCAINEPRODUCT MAX GROUP INCba75b129-7939-4373-91f5-1772976e6d612023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC441c802f-a363-1530-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC4939a547-c94b-3350-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
DR REAL NUMB Topical AnorectalLIDOCAINEFUZZYLULU LLC378d8edc-2120-416d-854c-8881c2950efe2023-11-09WarningsExact identifier
application number: M015
The Pharma C Company Medicated Foam with Witch HazelWITCH HAZELKleen Test Products Corporation1a1fbe83-be45-4654-a7bb-e934e1ccd0c62023-11-09WarningsExact identifier
application number: M015
The Pharma-C Company Medicated Hemorrhoidal PadsWITCH HAZELKleen Test Products Corporation357703ab-4e7a-41f6-9ecf-aa98acc2d92e2023-11-09WarningsExact identifier
application number: M015
DOCTORS TOUCH Erase The Pain LidocaineLIDOCAINE HYDROCHLORIDEDOCTOR'S CHOICE MEDICAL, LLC3dc9947b-8196-4a38-97b4-c2340ee77e0f2023-11-06WarningsExact identifier
application number: M015
SCALAR Pain Relief CreamMENTHOLMiracle Balance, LLC52a13cfe-3f46-45f8-a5af-ce07ea5758e32023-11-06WarningsExact identifier
application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief CreamPHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDESIMPLE PROMISE PTE LTDf6622caa-3b31-9b07-e053-2a95a90a8a512023-11-06WarningsExact identifier
application number: M015
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsExact identifier
application number: M015
SECONDARY NUMB Lidocaine Phenylephrine GelLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDELALANI Rx Consulting, Inc.0f13f7b5-e3b1-451e-a6d6-e7e15bd044432023-11-06WarningsExact identifier
application number: M015
Brazzers Anal DesensitizingLIDOCAINEMetro Media Entceacd80c-0dd6-4e21-97da-56da877b1c902023-11-06WarningsExact identifier
application number: M015
NUMB PLUS Maximum Strength AnorectalLIDOCAINESEENEXT VENTURE LTDa7c37b2a-b647-43d7-b43b-87bbece354302023-11-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN03b159b0-b960-b38d-e063-6394a90a94622
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD03b159b0-b960-b38d-e063-6394a90a94622
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY03b159b0-b960-b38d-e063-6394a90a94622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-323-01137090323014 BLISTER PACK in 1 CARTON (13709-323-01) / 6 CAPSULE in 1 BLISTER PACK / 2 g in 1 CAPSULE4 blister pack2023-08-24NoNoCurrent