FDA.reportPublic FDA data

careone hemorrhoidal

Product NDC
41520-188
11-digit product format
415200188
Labeler code
41520
Product ID
41520-188_71bc5a9e-e649-411e-b29e-519ff1377848
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
American Sales Company
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-20
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
careone 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
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
41520-188-16careone hemorrhoidal1 in 1 CARTONOINTMENT15
41520-188-16careone hemorrhoidal57 g in 1 TUBEOINTMENT575

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
MINERAL OILACTIVE MOIETYT5L8T28FGPCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PETROLATUMACTIVE MOIETY4T6H12BN9UCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
CORN OILINACTIVE INGREDIENT8470G57WFMCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HECAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZECAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
THYME OILINACTIVE INGREDIENT2UK410MY6BCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-188CAREONE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 2 package rows20241019_46794d2e-8fe6-490d-9cfa-ba9b6c209ad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN46794d2e-8fe6-490d-9cfa-ba9b6c209ad65
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD46794d2e-8fe6-490d-9cfa-ba9b6c209ad65
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY46794d2e-8fe6-490d-9cfa-ba9b6c209ad65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-188-16415200188161 TUBE in 1 CARTON (41520-188-16) / 57 g in 1 TUBE1 tube2014-07-200000-00-00NoNoCurrent