FDA.reportPublic FDA data

Family Wellness Hemorrhoidal

Product NDC
55319-381
11-digit product format
553190381
Labeler code
55319
Product ID
55319-381_41c4b3ad-4c73-7b02-e063-6294a90a60d1
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, and Phenylephrine HCL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Family Dollar Services, Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-18
Substance
PETROLATUM; MINERAL OIL; PHENYLEPHRINE HYDROCHLORIDE
Active strength
749; 140; 2.5 mg/g; mg/g; mg/g
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-381-56IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-381-56IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-381-56IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-381-56IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-381-56UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-381-56UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-381-56UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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 Wellness Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM749 mg/g
MINERAL OIL140 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
T5L8T28FGPInternal 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
fe3293bc-80b5-b60a-e053-6394a90a4edeAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-07-22Family Wellness Hemorrhoid Ointment 2oz 91319
2025-07-22Family Wellness Hemorrhoid Ointment 2oz 91319
2025-01-30Family Wellness Hemorrhoid Ointment 2oz 91319
2025-01-30Family Wellness Hemorrhoid Ointment 2oz 91319

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-381-56Family Wellness Hemorrhoidal1 in 1 CARTONOINTMENT15
55319-381-56Family Wellness Hemorrhoidal57 g in 1 TUBEOINTMENT575

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-381FAMILY WELLNESS HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL) OINTMENT [FAMILY DOLLAR SERVICES, INC]2Current NDC, 2 package rows20230927_fe3293bc-80b5-b60a-e053-6394a90a4ede.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 8 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
application number: M015
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
application number: M015
Hemorrhoidal Hygiene padsWITCH HAZELAkron Pharma Inc.936a0cca-5049-4ddf-9581-75c2da6d9cfa2026-01-12WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4805ba4e-45d3-bf0a-e063-6294a90a6eef2026-01-10WarningsExact identifier
application number: M015
THE SOLUTION 2.0LIDOCAINESCALP TECH INC0fa423b6-cc0f-b569-e063-6294a90a239e2026-01-09WarningsExact identifier
application number: M015
BLACK LABEL B NUMBLIDOCAINE HYDROCHLORIDESCALP TECH INC11fcf401-0891-04bc-e063-6294a90a8ad52026-01-09WarningsExact identifier
application number: M015
GOLD LABEL B NUMBLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INC1211590a-13b5-2e75-e063-6394a90a0f862026-01-09WarningsExact identifier
application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47dda425-86d8-441e-e063-6294a90a0f9a2026-01-08WarningsExact identifier
application number: M015
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
application number: M015
PREPARATION H FOR WOMENWITCH HAZELHaleon US Holdings LLCa9099cf4-4e2e-4cf1-a52f-48f8e174cb152026-01-08WarningsExact identifier
application number: M015
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
application number: M015
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M015
Dr Wellskin Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47ebedc5-caf1-a774-e063-6394a90ae14d2026-01-08WarningsExact identifier
application number: M015
Dr. Care Numbing CreamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47c94198-7718-bbc2-e063-6294a90a48f12026-01-07WarningsExact identifier
application number: M015
Healthwise Anorectal Pain ReliefLIDOCAINE 5%Veridian Healthcare19c24e1b-a31b-478b-a48b-c39bb4753ca72026-01-06WarningsExact identifier
application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact 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 OintmentPSNfe3293bc-80b5-b60a-e053-6394a90a4ede5
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDfe3293bc-80b5-b60a-e053-6394a90a4ede5
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYfe3293bc-80b5-b60a-e053-6394a90a4ede5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-381-56553190381561 TUBE in 1 CARTON (55319-381-56) / 57 g in 1 TUBE1 tube2023-09-18NoNoCurrent