FDA.reportPublic FDA data

HemorrhoidalOintment

Product NDC
69396-020
11-digit product format
693960020
Labeler code
69396
Product ID
69396-020_37247f04-c552-7e53-e063-6394a90a162e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-04
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
69396-020-052023-01-30C16284748780-1f386c649-bd82-0266-e053-dadaa90a7c1aHemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-020-01HemorrhoidalOintment1 in 1 BOXOINTMENT110
69396-020-01HemorrhoidalOintment28.4 g in 1 TUBEOINTMENT28.410
69396-020-02HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-02HemorrhoidalOintment1 in 1 BOXOINTMENT110
69396-020-33HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-33HemorrhoidalOintment3 in 1 BOXOINTMENT310
69396-020-44HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-44HemorrhoidalOintment4 in 1 BOXOINTMENT410
69396-020-05HemorrhoidalOintment1 in 1 BOXOINTMENT12
69396-020-05HemorrhoidalOintment15 g in 1 TUBEOINTMENT152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-020HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]9Current NDC, Legacy NDC, 8 package rows20250305_4eb3c9ac-268a-5246-e054-00144ff88e88.zip
69396-020HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, Legacy NDC, 2 package rows20171120_44cfb486-a5fd-10ee-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN4eb3c9ac-268a-5246-e054-00144ff88e8810
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD4eb3c9ac-268a-5246-e054-00144ff88e8810
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY4eb3c9ac-268a-5246-e054-00144ff88e8810
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN44cfb486-a5fd-10ee-e054-00144ff8d46c2
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD44cfb486-a5fd-10ee-e054-00144ff8d46c2
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY44cfb486-a5fd-10ee-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-020-01693960020011 TUBE in 1 BOX (69396-020-01) / 28.4 g in 1 TUBE1 tube2020-09-140000-00-00NoNoCurrent
69396-020-02693960020021 TUBE in 1 BOX (69396-020-02) / 56 g in 1 TUBE1 tube2017-05-040000-00-00NoNoCurrent
69396-020-05693960020051 TUBE in 1 BOX (69396-020-05) > 15 g in 1 TUBE1 tube2016-12-290000-00-00NoNoCurrent
69396-020-33693960020333 TUBE in 1 BOX (69396-020-33) / 56 g in 1 TUBE3 tube2024-03-12NoNoCurrent
69396-020-44693960020444 TUBE in 1 BOX (69396-020-44) / 56 g in 1 TUBE4 tube2024-03-12NoNoCurrent