FDA.reportPublic FDA data

Family Care Hemorrhoidal

Product NDC
65923-003
11-digit product format
659230003
Labeler code
65923
Product ID
65923-003_41c4a856-fbf0-657d-e063-6294a90a599f
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil
Dosage form
OINTMENT
Route
TOPICAL
Labeler
United Exchange Corp
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-24
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140; 749; 2.5 mg/100g; mg/100g; mg/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
Family Care Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL140 mg/100g
PETROLATUM749 mg/100g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04375257-f4f3-48c3-a338-de43298b95ebAvailable on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
65923-003-20Family Care Hemorrhoidal20 g in 1 TUBEOINTMENT2013
65923-003-20Family Care Hemorrhoidal1 in 1 CARTONOINTMENT113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
PETROLATUMACTIVE INGREDIENT4T6H12BN9UFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
MINERAL OILACTIVE MOIETYT5L8T28FGPFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
PETROLATUMACTIVE MOIETY4T6H12BN9UFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0FAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
LANOLININACTIVE INGREDIENT7EV65EAW6HFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
THYME OILINACTIVE INGREDIENT2UK410MY6BFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FFAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-003FAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]12Current NDC, Legacy NDC, 2 package rows20241228_04375257-f4f3-48c3-a338-de43298b95eb.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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Cooling GelPHENYLEPHRINE HCL, WITCH HAZELHaleon US Holdings LLCcebee3f7-8591-e4f7-e66a-e43b4ba3aaf42024-04-05WarningsExact identifier
application number: M015
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
application number: M015
Preparation HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZELHaleon US Holdings LLC2f370875-0225-47b7-b43f-8fa4600d2a0e2024-04-05WarningsExact identifier
application number: M015
PREPARATION HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa23ded81-78ba-c199-a8f0-aaf360b216ff2024-03-02WarningsExact identifier
application number: M015
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
application number: M015
PREPARATION H HYDROCORTISONEHYDROCORTISONEHaleon US Holdings LLCb8d531eb-4012-0450-0e4b-70a8084640412024-02-29WarningsExact identifier
application number: M015
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
application number: M015
Numquick AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.b66e7a91-9e35-64dd-e053-2a95a90a8b832024-02-28WarningsExact identifier
application number: M015
Medicated Wipes Hemorroidal Wipes With Witch HazelWITCH HAZELWuhan Zonsen Medical Products Co., Ltd.12441e46-5490-d45c-e063-6394a90a39e32024-02-26WarningsExact identifier
application number: M015
Lidocaine HemorrhoidLIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZELWalgreens Co10a47899-f4a0-66e8-e063-6394a90a11dd2024-02-05WarningsExact identifier
application number: M015
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
application number: M015
RRHOID RAGE HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLCa02a6398-0acd-4aa7-8320-ac586ff12eb32024-01-31WarningsExact identifier
application number: M015
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
application number: M015
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
application number: M015
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCICardinal Health 110 dba LEADERa5a261c2-1f36-c895-e053-2a95a90ab22b2024-01-02WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLProficient Rx LP105095e3-843e-4153-adc9-266dd14929a22024-01-01WarningsExact identifier
application number: M015
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-003-20659230003201 TUBE in 1 CARTON (65923-003-20) / 20 g in 1 TUBE1 tube2014-11-240000-00-00NoNoCurrent