FDA.reportPublic FDA data

Hemorrhoidal

Product NDC
70795-1021
11-digit product format
707951021
Labeler code
70795
Product ID
70795-1021_46d4393d-b3e0-9755-e063-6294a90aced8
Type
HUMAN OTC DRUG
Nonproprietary name
COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
GRAXCELL PHARMACEUTICAL, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-29
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1768.8; 5 mg/1; mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER1768.8 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii512OYT1CRR, 04JA59TNSJ
Rxcui1438497

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-1021-22025-12-26C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42025-12-26C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22024-01-30C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42024-01-30C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22020-11-16C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42020-11-16C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22020-01-31C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42020-01-31C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-1021-2Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18
70795-1021-2Hemorrhoidal12 in 1 BOXSUPPOSITORY128
70795-1021-4Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18
70795-1021-4Hemorrhoidal24 in 1 BOXSUPPOSITORY248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-1021-2EA - Each70795-102128ec95ae-d4d6-4b36-b307-9a586286b34212017-10-13
70795-1021-4EA - Each70795-10213cbf5c99-ff79-4627-b851-2f55ceb6deee12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70795-1021HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [GRAXCELL PHARMACEUTICAL, LLC]7Current NDC, Legacy NDC, 4 package rows20211222_5162baee-0d63-494e-8046-459437b85348.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN5162baee-0d63-494e-8046-459437b853488
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD5162baee-0d63-494e-8046-459437b853488
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY5162baee-0d63-494e-8046-459437b853488

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70795-1021-27079510210212 BLISTER PACK in 1 BOX (70795-1021-2) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2017-03-290000-00-00NoNoCurrent
70795-1021-47079510210424 BLISTER PACK in 1 BOX (70795-1021-4) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2017-04-220000-00-00NoNoCurrent