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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-28830573-2883-10DDiscontinued by firm2026-10-12
excluded packagepackage0573-28830573-2883-11DDiscontinued by firm2026-10-12
excluded packagepackage0573-28830573-2883-20DDiscontinued by firm2026-10-12
excluded packagepackage0573-28830573-2883-30DDiscontinued by firm2026-10-12
excluded packagepackage0573-28830573-2883-55DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2883-20DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2883-55DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2883-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2883-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2883-11DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2883-20DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2883-55DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2883-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2883-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2883-11DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2883-20DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2883-55DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2883-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2883-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2883-11DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2883-20DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2883-55DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2883-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2883-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2883-11DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2883-20DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2883-55DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2883-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2883-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2883-11DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2883-20DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2883-55DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2883-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2883-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2883-11DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2883-20DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2883-55DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2883-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2883-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2883-11DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2883-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2883-55DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2883-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2883-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2883-11DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2883-20DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2883-55DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2883-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2883-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2883-11DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2883-20DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2883-55DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2883-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2883-30DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2883-11DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2883-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2883-11IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2883-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2883-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2883-55IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2883-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2883-11IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2883-20IInactivated by FDA86f5da6cb304…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
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
512OYT1CRRInternal 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
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a23ded81-78ba-c199-a8f0-aaf360b216ffAvailable 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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0573-2883-102023-05-17Drug Facts
0573-2883-112023-05-17Drug Facts
0573-2883-202023-05-17Drug Facts
0573-2883-302023-05-17Drug Facts
0573-2883-552023-05-17Drug Facts
0573-2883-102022-01-28Drug Facts
0573-2883-112022-01-28Drug Facts
0573-2883-202022-01-28Drug Facts
0573-2883-302022-01-28Drug Facts
0573-2883-552022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2883-10PREPARATION H12 in 1 CARTONSUPPOSITORY1218
0573-2883-10PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118
0573-2883-11PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118
0573-2883-11PREPARATION H12 in 1 CARTONSUPPOSITORY1218
0573-2883-20PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118
0573-2883-20PREPARATION H24 in 1 CARTONSUPPOSITORY2418
0573-2883-30PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118
0573-2883-30PREPARATION H48 in 1 CARTONSUPPOSITORY4818
0573-2883-55PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118
0573-2883-55PREPARATION H56 in 1 CARTONSUPPOSITORY5618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2883-10EA - Each0573-2883373d7bb4-6a34-445e-8ed9-414e765db74e12012-07-24
0573-2883-11EA - Each0573-2883e14cdc2f-07ae-41e3-badf-5eacdb4ff96912017-03-06
0573-2883-20EA - Each0573-28839a9b01fd-67bf-4599-a5c7-29fbfa7d9a6012012-07-24
0573-2883-30EA - Each0573-2883ccc9e478-d835-4450-bc2b-2399ccf1eff012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2883PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 10 package rows20240303_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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMITSUI MEDICAL HAEMORRHOIDPHENYLEPHRINE HCI WITCH HAZELYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED51720221-893b-cade-e063-6394a90adaec2026-05-10WarningsExact identifier
application number: M015
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Inc32ab24b4-dcec-4a09-e054-00144ff88e882026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Incc2c0cb17-401a-4ba2-aa04-64c9b43cd21b2026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsExact identifier
application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPESWITCH HAZELFamily Dollar Stores, Inc3f6f68c0-787a-48eb-b042-d4df90ea7e032026-04-17WarningsExact identifier
application number: M015
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTSLIDOCAINE, PHENYLEPHRINEGuangdong Quadrant Ecological Technology Co., Ltd.4f1634d5-7667-b354-e063-6394a90a34e72026-04-10WarningsExact identifier
application number: M015
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
application number: M015
Walgreens Pain Relief with LidocaineLIDOCAINE, PHENYLEPHRINE HCLWalgreens Co3ce78f2f-0264-f406-e063-6294a90a7e032026-04-01WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp5256a84a-8dac-8fd4-e063-6294a90a616c2026-04-01WarningsExact identifier
application number: M015
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
application number: M015
Critic Aid SkinZINC OXIDEColoplast Corpcaaac1f0-437d-4185-8670-9f11b9cefe632026-03-30WarningsExact identifier
application number: M015
CVS Topical Analgesic HemorrhoidalDIBUCAINECVS PHARMACY,INCb9e20531-3444-4955-b1d3-bb112340d2302026-03-27WarningsExact identifier
application number: M015
Walgreens Moisture BarrierWALGREENS MOISTURE BARRIERWalgreens44fc098c-1f5f-bf82-e063-6294a90a14052026-03-25WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp472fe0d1-31a1-fded-e063-6394a90a4a662026-03-25WarningsExact identifier
application number: M015
Hemorrhoid Relief CreamLIDOCAINE 5% ANORECTALALAINA HEALTHCARE PRIVATE LIMITED53b2c3b0-d729-44d6-bc64-a9e1c93518772026-03-23WarningsExact identifier
application number: M015
LIDOCAINELIDOCAINEYYBA Corp4db609cc-f329-62a4-e063-6394a90aefc12026-03-23WarningsExact identifier
application number: M015
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNa23ded81-78ba-c199-a8f0-aaf360b216ff18
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDa23ded81-78ba-c199-a8f0-aaf360b216ff18
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYa23ded81-78ba-c199-a8f0-aaf360b216ff18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2883-100057328831012 BLISTER PACK in 1 CARTON (0573-2883-10) > 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2004-01-050000-00-00NoNoCurrent
0573-2883-110057328831112 BLISTER PACK in 1 CARTON (0573-2883-11) > 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2004-01-050000-00-00NoNoCurrent
0573-2883-200057328832024 BLISTER PACK in 1 CARTON (0573-2883-20) > 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2004-01-050000-00-00NoNoCurrent
0573-2883-300057328833048 BLISTER PACK in 1 CARTON (0573-2883-30) > 1 SUPPOSITORY in 1 BLISTER PACK48 blister pack2004-01-050000-00-00NoNoCurrent
0573-2883-550057328835556 BLISTER PACK in 1 CARTON (0573-2883-55) > 1 SUPPOSITORY in 1 BLISTER PACK56 blister pack2004-01-050000-00-00NoNoCurrent