FDA.reportPublic FDA data

Hemorrhoidal Pain Relief

Product NDC
0363-9876
11-digit product format
003639876
Labeler code
0363
Product ID
0363-9876_0bd10784-ac3f-815b-e063-6294a90a786b
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil, Petrolatum, Phenylephrine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WALGREENS
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
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
Hemorrhoidal Pain Relief
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9876-02Hemorrhoidal Pain Relief28 g in 1 TUBEOINTMENT282
0363-9876-02Hemorrhoidal Pain Relief1 in 1 CARTONOINTMENT12
0363-9876-04Hemorrhoidal Pain Relief1 in 1 CARTONOINTMENT12
0363-9876-04Hemorrhoidal Pain Relief57 g in 1 TUBEOINTMENT572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9876HEMORRHOIDAL PAIN RELIEF (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WALGREENS]2Current NDC, 4 package rows20240115_03bc5c1a-d493-5082-e063-6394a90ae87b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN03bc5c1a-d493-5082-e063-6394a90ae87b2
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD03bc5c1a-d493-5082-e063-6394a90ae87b2
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY03bc5c1a-d493-5082-e063-6394a90ae87b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9876-02003639876021 TUBE in 1 CARTON (0363-9876-02) / 28 g in 1 TUBE1 tube2024-01-15NoNoHistorical
0363-9876-04003639876041 TUBE in 1 CARTON (0363-9876-04) / 57 g in 1 TUBE1 tube2024-01-15NoNoHistorical