FDA.reportPublic FDA data

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
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140; 749; 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

Additional Listing Data#

Finished product
Yes
Brand name base
PREPARATION H
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE140 mg/g
MINERAL OIL749 mg/g
PETROLATUM2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, T5L8T28FGP, 4T6H12BN9U
Rxcui1372298

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

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