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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9f12a34-7bd1-4ba5-b34b-1b641f58271aAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
application number: M015
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
application number: M015
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
application number: M015
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
application number: M015
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
application number: M015
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
application number: M015
Calmol 4ZINC OXIDE AND COCOA BUTTERResical Inc.5516f800-d3fa-4b90-a3eb-c0bdf3183b9b2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
application number: M015
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
application number: M015
AmericaineBENZOCAINEInsight Pharmaceuticals LLCd13c022f-2f91-40b4-bd66-0cfc0e147a5f2025-10-23WarningsExact identifier
application number: M015
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
application number: M015
Signature Care Medicated CoolingWITCH HAZELBetter Living Brands, LLCb35dc719-a5a2-4839-870d-25313d3f7c9b2025-10-22WarningsExact identifier
application number: M015
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
application number: M015
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
application number: M015
Xesso Rear Comfort GlideLIDOCAINEPREMIUM NATURAL COSMETICS INCe9eb262e-a1c1-7d5c-e053-2a95a90a7c9f2025-10-22WarningsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.41a6d309-2722-1738-e063-6294a90a8a702025-10-21WarningsExact identifier
application number: M015
DERMOSCRIBE ICHYBUMHYDROCORTISONE, CLIOQUINOL, ZINC OXIDEDERMOSCRIBE PTY LTD134a88a1-13e5-4da0-8270-c380b57aaeb72025-10-17WarningsExact identifier
application number: M015

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