FDA.reportPublic FDA data

Good Sense Hemorrhoidal

Product NDC
0113-0188
11-digit product format
001130188
Labeler code
0113
Product ID
0113-0188_e07a1655-f8cb-4f3e-be58-d4ef3e3193c4
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
L. Perrigo Company
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-21
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

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Hemorrhoidal
Listing expiration
2026-12-31

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
0113-0188-16Good Sense Hemorrhoidal1 in 1 CARTONOINTMENT14
0113-0188-16Good Sense Hemorrhoidal57 g in 1 TUBEOINTMENT574

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0188-16GM - Gram0113-0188310ab1d1-4d70-49f7-a255-546eeae6443212015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
MINERAL OILACTIVE MOIETYT5L8T28FGPGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PETROLATUMACTIVE MOIETY4T6H12BN9UGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0GOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
CORN OILINACTIVE INGREDIENT8470G57WFMGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
LANOLININACTIVE INGREDIENT7EV65EAW6HGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
THYME OILINACTIVE INGREDIENT2UK410MY6BGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FGOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0188GOOD SENSE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 2 package rows20241019_2492ee1b-01f1-46e7-8790-b6ebc48f2aff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN2492ee1b-01f1-46e7-8790-b6ebc48f2aff4
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD2492ee1b-01f1-46e7-8790-b6ebc48f2aff4
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY2492ee1b-01f1-46e7-8790-b6ebc48f2aff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0188-16001130188161 TUBE in 1 CARTON (0113-0188-16) / 57 g in 1 TUBE1 tube2013-11-210000-00-00NoNoCurrent