FDA.reportPublic FDA data

GNP Hemorrhoidal

Product NDC
46122-677
11-digit product format
461220677
Labeler code
46122
Product ID
46122-677_4262f482-1e78-4db0-e063-6394a90aff1b
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil, Petrolatum, Phenylephrine, HCL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-26
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140; 749; 2.5 mg/g; 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL140 mg/g
PETROLATUM749 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Rxcui1372298

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
46122-677-46GNP Hemorrhoidal57 g in 1 TUBEOINTMENT576
46122-677-46GNP Hemorrhoidal1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-677-46GM - Gram46122-677e92c91df-11e0-4816-8468-879f4119acd312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-677GNP HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL) OINTMENT [AMERISOURCE BERGEN]5Current NDC, Legacy NDC, 2 package rows20241212_b0f0ef97-9add-717f-e053-2a95a90a0eb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNb0f0ef97-9add-717f-e053-2a95a90a0eb06
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDb0f0ef97-9add-717f-e053-2a95a90a0eb06
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYb0f0ef97-9add-717f-e053-2a95a90a0eb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-677-46461220677461 TUBE in 1 CARTON (46122-677-46) / 57 g in 1 TUBE1 tube2021-03-120000-00-00NoNoCurrent