Home NDC 0573-2883 PREPARATION H
Product NDC 0573-2883
11-digit product format 005732883
Labeler code 0573
Product ID 0573-2883_12ad4740-7bea-f822-e063-6394a90a0e38
Type HUMAN OTC DRUG
Nonproprietary name cocoa butter, phenylephrine hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Haleon US Holdings LLC
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-05
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2211; 6.25 mg/1; mg/1
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 2 · 68 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0573-2883-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0573-2883-55 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0573-2883-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0573-2883-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0573-2883-11 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0573-2883-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0573-2883-55 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0573-2883-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0573-2883-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0573-2883-11 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0573-2883-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0573-2883-55 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0573-2883-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0573-2883-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0573-2883-11 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0573-2883-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0573-2883-55 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0573-2883-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0573-2883-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0573-2883-11 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0573-2883-20 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0573-2883-55 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0573-2883-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0573-2883-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0573-2883-11 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0573-2883-20 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0573-2883-55 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0573-2883-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0573-2883-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0573-2883-11 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0573-2883-20 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0573-2883-55 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0573-2883-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0573-2883-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0573-2883-11 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0573-2883-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0573-2883-55 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0573-2883-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0573-2883-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0573-2883-11 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0573-2883-20 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0573-2883-55 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0573-2883-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0573-2883-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0573-2883-11 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0573-2883-20 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0573-2883-55 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0573-2883-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0573-2883-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0573-2883-11 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2883-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2883-11 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2883-20 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2883-10 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2883-55 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0573-2883-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0573-2883-11 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0573-2883-20 I Inactivated by FDA 86f5da6cb304…a595104c45d7…
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 PREPARATION H
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COCOA BUTTER 2211 mg/1 PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 512OYT1CRR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1438497 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COCOA BUTTER ACTIVE INGREDIENT 512OYT1CRR PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 COCOA BUTTER ACTIVE MOIETY 512OYT1CRR PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-2883 PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC] 18 Current NDC, Legacy NDC, 10 package rows 20240303_a23ded81-78ba-c199-a8f0-aaf360b216ff.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 Marketing end Sample Exclude flag Status 0573-2883-10 00573288310 12 BLISTER PACK in 1 CARTON (0573-2883-10) > 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2004-01-05 0000-00-00 No No Current 0573-2883-11 00573288311 12 BLISTER PACK in 1 CARTON (0573-2883-11) > 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2004-01-05 0000-00-00 No No Current 0573-2883-20 00573288320 24 BLISTER PACK in 1 CARTON (0573-2883-20) > 1 SUPPOSITORY in 1 BLISTER PACK 24 blister pack 2004-01-05 0000-00-00 No No Current 0573-2883-30 00573288330 48 BLISTER PACK in 1 CARTON (0573-2883-30) > 1 SUPPOSITORY in 1 BLISTER PACK 48 blister pack 2004-01-05 0000-00-00 No No Current 0573-2883-55 00573288355 56 BLISTER PACK in 1 CARTON (0573-2883-55) > 1 SUPPOSITORY in 1 BLISTER PACK 56 blister pack 2004-01-05 0000-00-00 No No Current