FDA.reportPublic FDA data

DG Health Hemorrhoidal

Product NDC
55910-188
11-digit product format
559100188
Labeler code
55910
Product ID
55910-188_f7928cf0-1b75-4f71-a1bb-3bef934b351d
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
Dolgencorp, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DG Health 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-188-16DG Health Hemorrhoidal1 in 1 CARTONOINTMENT16
55910-188-16DG Health Hemorrhoidal57 g in 1 TUBEOINTMENT576

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
MINERAL OILACTIVE MOIETYT5L8T28FGPDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
CORN OILINACTIVE INGREDIENT8470G57WFMDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
LANOLININACTIVE INGREDIENT7EV65EAW6HDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
THYME OILINACTIVE INGREDIENT2UK410MY6BDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FDG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-188DG HEALTH HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 2 package rows20241031_d9f12a34-7bd1-4ba5-b34b-1b641f58271a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNd9f12a34-7bd1-4ba5-b34b-1b641f58271a6
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDd9f12a34-7bd1-4ba5-b34b-1b641f58271a6
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYd9f12a34-7bd1-4ba5-b34b-1b641f58271a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-188-16559100188161 TUBE in 1 CARTON (55910-188-16) / 57 g in 1 TUBE1 tube2013-12-200000-00-00NoNoCurrent