FDA.reportPublic FDA data

SHOPKO HEMORRHOIDAL

Product NDC
65923-777
11-digit product format
659230777
Labeler code
65923
Product ID
65923-777_7efa7bd4-6f86-46bf-9ebc-2ca3fcc88edc
Type
HUMAN OTC DRUG
Nonproprietary name
MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
UNITED EXCHANGE CORP.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-03-21
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
Active strength
140 mg/g; 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
65923-777-882019-10-29C16284748780-1960f7f55-c125-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-777-88SHOPKO HEMORRHOIDAL57 g in 1 TUBEOINTMENT573
65923-777-88SHOPKO HEMORRHOIDAL1 in 1 CARTONOINTMENT13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PETROLATUMACTIVE INGREDIENT4T6H12BN9USHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
SHARK LIVER OILACTIVE INGREDIENT4B24275HEUSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
MINERAL OILACTIVE MOIETYT5L8T28FGPSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PETROLATUMACTIVE MOIETY4T6H12BN9USHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
SHARK LIVER OILACTIVE MOIETY4B24275HEUSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PARAFFININACTIVE INGREDIENTI9O0E3H2ZESHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
THYME OILINACTIVE INGREDIENT2UK410MY6BSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RSHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-777SHOPKO HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL) OINTMENT [UNITED EXCHANGE CORP.]3Legacy NDC, 2 package rows20110414_3fb14a39-919e-4a2a-a089-052598bebbc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544968mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal OintmentPSN3fb14a39-919e-4a2a-a089-052598bebbc43
1544968mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal OintmentSCD3fb14a39-919e-4a2a-a089-052598bebbc43
1544968mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal OintmentSY3fb14a39-919e-4a2a-a089-052598bebbc43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65923-777-886592307778857 g in 1 TUBE57 gHistorical