0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL

Product NDC
43473-094
11-digit product format
434730094
Labeler code
43473
Product ID
43473-094_4a213e22-fced-2f93-e063-6394a90ab436
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine Hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43473-094-020.25 % PHENYLEPHRINE HCl HEMORRHOIDAL57 g in 1 TUBEOINTMENT571
43473-094-020.25 % PHENYLEPHRINE HCl HEMORRHOIDAL1 in 1 BOXOINTMENT11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1cada0ae-3f0f-441c-a633-faa0a3009d2b1
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1cada0ae-3f0f-441c-a633-faa0a3009d2b1
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY1cada0ae-3f0f-441c-a633-faa0a3009d2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43473-094-02434730094021 TUBE in 1 BOX (43473-094-02) / 57 g in 1 TUBE1 tube2026-02-05NoNoHistorical