FDA.reportPublic FDA data

HemorrhoidalOintment

Product NDC
68016-528
11-digit product format
680160528
Labeler code
68016
Product ID
68016-528_29b76842-546d-6826-e063-6294a90a20a5
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmacy Value Alliance, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-19
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 g/100g; g/100g; g/100g
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
HemorrhoidalOintment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-528-002023-03-02C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002023-01-30C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002021-10-26C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002021-01-29C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-528-00HemorrhoidalOintment57 g in 1 TUBEOINTMENT575
68016-528-00HemorrhoidalOintment1 in 1 BOXOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-528HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]5Current NDC, Legacy NDC, 2 package rows20241222_3803a61b-308a-14a9-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN3803a61b-308a-14a9-e054-00144ff88e885
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3803a61b-308a-14a9-e054-00144ff88e885
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3803a61b-308a-14a9-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-528-00680160528001 TUBE in 1 BOX (68016-528-00) / 57 g in 1 TUBE1 tube2016-07-190000-00-00NoNoCurrent