FDA.reportPublic FDA data

Mineral Oil, Petrolatum and Phenylephrine HCl

Product NDC
49743-3047
11-digit product format
497433047
Labeler code
49743
Product ID
49743-3047_d763cf0b-a67f-490c-852d-ce795fa6e62f
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Axcentria Pharmaceuticals, LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-28
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140 mg/g; mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
49743-3047-12019-11-27C16284748780-19855d018-d70f-cd31-e053-dbdaa90ab51aHemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49743-3047-1Mineral Oil, Petrolatum and Phenylephrine HCl1 in 1 CARTONOINTMENT11
49743-3047-1Mineral Oil, Petrolatum and Phenylephrine HCl56.8 g in 1 TUBEOINTMENT56.81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
MINERAL OILACTIVE MOIETYT5L8T28FGPMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
CORN OILINACTIVE INGREDIENT8470G57WFMMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
THYMEINACTIVE INGREDIENTCW657OBU4NMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49743-3047MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AXCENTRIA PHARMACEUTICALS, LLC]1Legacy NDC, 2 package rows20130709_9ea3b4ec-ad69-45fc-91d6-ffd9ee312591.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313818mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN9ea3b4ec-ad69-45fc-91d6-ffd9ee3125911
1313818mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD9ea3b4ec-ad69-45fc-91d6-ffd9ee3125911
1313818mineral oil 14 % / petrolatum 71.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY9ea3b4ec-ad69-45fc-91d6-ffd9ee3125911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49743-3047-1497433047011 in 1 CARTONHistorical