FDA.reportPublic FDA data

Good Sense Hemorrhoidal

Product NDC
0113-0944
11-digit product format
001130944
Labeler code
0113
Product ID
0113-0944_bbd95360-7410-4ba0-8310-169ff8caba8e
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
L. Perrigo Company
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-02-28
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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
Good Sense Hemorrhoidal
Brand name suffix
Maximum Strength Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN14.4 g/100g
PETROLATUM15 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
Rxcui1293649

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0944-24Good Sense HemorrhoidalMaximum Strength Pain Relief1 in 1 CARTONCREAM15
0113-0944-24Good Sense HemorrhoidalMaximum Strength Pain Relief51 g in 1 TUBECREAM515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0944-24GM - Gram0113-09447a296da3-e0dd-4d0b-b196-8e5b1931e8ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
GLYCERINACTIVE MOIETYPDC6A3C0OXGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PETROLATUMACTIVE MOIETY4T6H12BN9UGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PRAMOXINEACTIVE MOIETY068X84E056GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0944GOOD SENSE HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 2 package rows20240927_1d6142b6-3746-46f1-99ec-4b19d26f056e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN1d6142b6-3746-46f1-99ec-4b19d26f056e5
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD1d6142b6-3746-46f1-99ec-4b19d26f056e5
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY1d6142b6-3746-46f1-99ec-4b19d26f056e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0944-24001130944241 TUBE in 1 CARTON (0113-0944-24) / 51 g in 1 TUBE1 tube2008-02-280000-00-00NoNoCurrent