Home NDC 55319-381 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55319-381-56 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55319-381-56 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55319-381-56 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55319-381-56 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55319-381-56 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55319-381-56 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55319-381-56 U Excluded because listing certification expired 0efc9e666f02…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 Ingredient Strength PETROLATUM 749 mg/g MINERAL OIL 140 mg/g PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup T5L8T28FGP Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1372298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-381-56 Family Wellness Hemorrhoidal 1 in 1 CARTON OINTMENT 1 5 55319-381-56 Family Wellness Hemorrhoidal 57 g in 1 TUBE OINTMENT 57 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-381 FAMILY WELLNESS HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL) OINTMENT [FAMILY DOLLAR SERVICES, INC] 2 Current NDC, 2 package rows 20230927_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 15 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BODY ACTION PRODUCTS Anal Glide Extra BENZOCAINE PRODUCT MAX GROUP INC 282ac8d3-2caf-42de-b347-450e9c7a9e50 2025-04-03 Warnings Exact identifier application number: M015 Numb 520 LIDOCAINE Clinical Resolution Laboratory, Inc. 984c4bee-0d44-4e0f-a057-0d54400c4cac 2025-04-02 Warnings Exact identifier application number: M015 hemorrhoidal MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL Bionpharma Inc. 1790da99-2a22-e2a2-e063-6394a90ac36f 2025-03-31 Warnings Exact identifier application number: M015 HemAway LIDOCAINE Melaleuca, Inc. cf842adf-fcd7-2c8c-e053-2995a90adea6 2025-03-27 Warnings Exact identifier application number: M015 Numb and Number Anorectal Cream LIDOCAINE Dermtech Labs, Inc 31420635-5021-173d-e063-6294a90a407a 2025-03-26 Warnings Exact identifier application number: M015 Leader Maximum Strength Hemorrhoidal Relief LIDOCAINE Cardinal Health,Inc. 65c780b0-7f47-4ae9-a847-c22deaaa2888 2025-03-21 Warnings Exact identifier application number: M015 Curist Hemorrhoid Fissure Relief LIDOCAINE Little Pharma, Inc 2fb02b00-acdb-5184-e063-6294a90ae1c8 2025-03-06 Warnings Exact identifier application number: M015 Thera Plus Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE FOURSTAR GROUP USA, INC. 87143a7a-7b2d-4b67-afda-2355697e7300 2025-03-04 Warnings Exact identifier application number: M015 Numbskin Maximum Strength Pain Reliever LIDOCAINE Shinpharma Inc 2f288bde-99fd-42f8-e063-6394a90a0f05 2025-02-27 Warnings Exact identifier application number: M015 PREPARATION H TOTABLES IRRITATION RELIEF WIPES WITCH HAZEL Haleon US Holdings LLC 1953ec64-20ce-488b-8f14-44e15cc9e720 2025-02-21 Warnings Exact identifier application number: M015 LBRI STOP THE PAIN Super Aloe Pain Relief Cream MENTHOL, METHYL SALICYLATE L'BRI HEALTH AND BEAUTY INC 62e18a37-c0db-4b1e-a6a1-35684cc00e08 2025-01-28 Warnings Exact identifier application number: M015 Hemorrhoidal PAIN RELIEF NeilMed Pharmaceuticals Inc. 038a2cf5-1b72-227b-e063-6394a90a84ad 2025-01-24 Warnings Exact identifier application number: M015 lidocaine LIDOCAINE Nivagen Pharmaceuticals, Inc. 32964ec3-1880-477b-9f71-2222c39106aa 2025-01-23 Warnings Exact identifier application number: M015 Hemorrhoidal cocoa butter HEMORRHOIDAL NeilMed Pharmaceuticals Inc. 03b159b0-b960-b38d-e063-6394a90a9462 2025-01-17 Warnings Exact identifier application number: M015 Gentle Laxative Bisacodyl GENTLE LAXATIVE BISACODYL NeilMed Pharmaceuticals Inc 03b3733a-4d78-149f-e063-6294a90a6518 2025-01-17 Warnings Exact identifier application number: M015 Glycerin Laxative GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF NeilMed Pharmaceuticals Inc. 03b4be69-6488-76be-e063-6394a90a7edf 2025-01-17 Warnings Exact identifier application number: M015 Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent WITCH HAZEL Walgreens Company 209a111b-d169-cb5d-e063-6394a90a33ca 2025-01-15 Warnings Exact identifier application number: M015 Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel WITCH HAZEL Walgreens Company 1e2dcec1-a1fe-71d2-e063-6394a90a9908 2025-01-15 Warnings Exact identifier application number: M015 AER Pre-moistened Witch Hazel Pad WITCH HAZEL Birchwood Laboratories LLC 1cca622f-0a6b-4f35-9355-34c249ee705e 2025-01-14 Warnings Exact identifier application number: M015 B-SURE Traveler Towelette B-SURE TRAVELER Birchwood Laboratories LLC e1a5da94-6a1a-497b-a737-1c1541bf0404 2025-01-14 Warnings Exact identifier application number: M015
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-381-56 55319038156 1 TUBE in 1 CARTON (55319-381-56) / 57 g in 1 TUBE 1 tube 2023-09-18 No No Current