FDA.reportPublic FDA data

hemorrhoidal

Product NDC
41250-188
11-digit product format
412500188
Labeler code
41250
Product ID
41250-188_e9dba367-987f-4e31-a8e7-d3e862998469
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
Meijer Distribution Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-05
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
2026-12-31
Current FDA listing
Yes

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-188-16hemorrhoidal57 g in 1 TUBEOINTMENT574
41250-188-16hemorrhoidal1 in 1 CARTONOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
MINERAL OILACTIVE MOIETYT5L8T28FGPHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
CORN OILINACTIVE INGREDIENT8470G57WFMHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
THYME OILINACTIVE INGREDIENT2UK410MY6BHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-188HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 2 package rows20241023_14319ba4-3bce-497c-a380-65bd24defc5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN14319ba4-3bce-497c-a380-65bd24defc5d4
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD14319ba4-3bce-497c-a380-65bd24defc5d4
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY14319ba4-3bce-497c-a380-65bd24defc5d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-188-16412500188161 TUBE in 1 CARTON (41250-188-16) / 57 g in 1 TUBE1 tube2014-03-050000-00-00NoNoCurrent