PREPARATION H

Product NDC
0573-2871
11-digit product format
005732871
Labeler code
0573
Product ID
0573-2871_128ba16d-dbb2-1073-e063-6394a90a8ba6
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-03-01
Substance
PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM
Active strength
2.5; 140; 749 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

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
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
MINERAL OIL140 mg/g
PETROLATUM749 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal 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
507c08ab-a98b-33fe-e2ac-eb9b9a810d5aAvailable 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
0573-2871-04PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-04PREPARATION H2 in 1 PACKAGEOINTMENT215
0573-2871-10PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-10PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-20PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-20PREPARATION H57 g in 1 TUBEOINTMENT5715
0573-2871-91PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-91PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-92PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-92PREPARATION H57 g in 1 TUBEOINTMENT5715
0573-2871-93PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-93PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-94PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-94PREPARATION H57 g in 1 TUBEOINTMENT5715

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2871-04GM - Gram0573-28717acfbc40-0747-4dab-93d8-ecd0f52ca0de12024-04-05
0573-2871-10GM - Gram0573-2871f6e5423c-bb14-4f8f-8bbd-1f3679784cc812012-07-24
0573-2871-20GM - Gram0573-2871929f7ea8-767f-4993-9b71-6f6fac08bc0c12012-07-24
0573-2871-93GM - Gram0573-2871bd4ee4db-92a0-4d12-bef1-730e16c84a4f12019-10-07
0573-2871-94GM - Gram0573-28712274dfaf-26cd-4e54-b4eb-c088146d00bd12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
MINERAL OILACTIVE MOIETYT5L8T28FGPPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PETROLATUMACTIVE MOIETY4T6H12BN9UPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
CORN OILINACTIVE INGREDIENT8470G57WFMPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
LANOLININACTIVE INGREDIENT7EV65EAW6HPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
THYMEINACTIVE INGREDIENTCW657OBU4NPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
WATERINACTIVE INGREDIENT059QF0KO0RPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2871PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [HALEON US HOLDINGS LLC]15Current NDC, Legacy NDC, 14 package rows20240302_507c08ab-a98b-33fe-e2ac-eb9b9a810d5a.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
ndc (product): 0573-2871
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN507c08ab-a98b-33fe-e2ac-eb9b9a810d5a15
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD507c08ab-a98b-33fe-e2ac-eb9b9a810d5a15
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY507c08ab-a98b-33fe-e2ac-eb9b9a810d5a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2871-04005732871042 CARTON in 1 PACKAGE (0573-2871-04) / 1 TUBE in 1 CARTON / 57 g in 1 TUBE2 carton2004-03-010000-00-00NoNoCurrent
0573-2871-10005732871101 TUBE in 1 CARTON (0573-2871-10) / 28 g in 1 TUBE1 tube2004-03-010000-00-00NoNoCurrent
0573-2871-20005732871201 TUBE in 1 CARTON (0573-2871-20) / 57 g in 1 TUBE1 tube2004-03-010000-00-00NoNoCurrent
0573-2871-91005732871911 TUBE in 1 CARTON (0573-2871-91) / 28 g in 1 TUBE1 tube2018-03-010000-00-00NoNoCurrent
0573-2871-92005732871921 TUBE in 1 CARTON (0573-2871-92) / 57 g in 1 TUBE1 tube2018-03-010000-00-00NoNoCurrent
0573-2871-93005732871931 TUBE in 1 CARTON (0573-2871-93) / 28 g in 1 TUBE1 tube2019-06-010000-00-00NoNoCurrent
0573-2871-94005732871941 TUBE in 1 CARTON (0573-2871-94) / 57 g in 1 TUBE1 tube2020-05-170000-00-00NoNoCurrent