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
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
MINERAL OIL	140 mg/g
PETROLATUM	749 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-2871-04	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-04	PREPARATION H	2 in 1 PACKAGE	OINTMENT	2	15
0573-2871-10	PREPARATION H	28 g in 1 TUBE	OINTMENT	28	15
0573-2871-10	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-20	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-20	PREPARATION H	57 g in 1 TUBE	OINTMENT	57	15
0573-2871-91	PREPARATION H	28 g in 1 TUBE	OINTMENT	28	15
0573-2871-91	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-92	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-92	PREPARATION H	57 g in 1 TUBE	OINTMENT	57	15
0573-2871-93	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-93	PREPARATION H	28 g in 1 TUBE	OINTMENT	28	15
0573-2871-94	PREPARATION H	1 in 1 CARTON	OINTMENT	1	15
0573-2871-94	PREPARATION H	57 g in 1 TUBE	OINTMENT	57	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2871-04	GM - Gram	0573-2871	7acfbc40-0747-4dab-93d8-ecd0f52ca0de	1	2024-04-05
0573-2871-10	GM - Gram	0573-2871	f6e5423c-bb14-4f8f-8bbd-1f3679784cc8	1	2012-07-24
0573-2871-20	GM - Gram	0573-2871	929f7ea8-767f-4993-9b71-6f6fac08bc0c	1	2012-07-24
0573-2871-93	GM - Gram	0573-2871	bd4ee4db-92a0-4d12-bef1-730e16c84a4f	1	2019-10-07
0573-2871-94	GM - Gram	0573-2871	2274dfaf-26cd-4e54-b4eb-c088146d00bd	1	2024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
THYME	INACTIVE INGREDIENT	CW657OBU4N	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PFIZER CONSUMER HEALTHCARE]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2871	PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [HALEON US HOLDINGS LLC]	15	Current NDC, Legacy NDC, 14 package rows	20240302_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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family wellness	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	FRONT PHARMACEUTICAL PLC	cfdd61e3-e12e-491c-b2a8-90fae19e8870	2023-10-27	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM	FRONT PHARMACEUTICAL PLC	eb1785f4-5876-443b-b175-9b59d65d1a48	2023-10-26	Warnings	Exact identifier application number: M015
CVS Health Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	FRONT PHARMACEUTICAL PLC	cb448d78-553c-4e65-80c5-d4b31d7b3661	2023-10-26	Warnings	Exact identifier application number: M015
Family Wellness	PHENYLEPHRINE HCL, PETROLATUM, MINERAL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bfa195d7-d87f-43b5-bbf1-7ec3a451de05	2023-10-25	Warnings	Exact identifier application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots	LIDOCAINE	CVS PHARMACY, INC	82aa128a-44cd-4907-b0f7-8a31e086d3e6	2023-10-25	Warnings	Exact identifier application number: M015
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier application number: M015
Assured Bikini Smooth Cream	LIDOCAINE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fb9ddde3-3f40-467e-8aff-26570144f0fc	2023-10-25	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Cardinal Health 110, LLC. dba Leader	85a51d5c-679e-1959-e053-2a91aa0a76d5	2023-10-25	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fde9cd90-d63c-4058-b46e-511fecea36ec	2023-10-24	Warnings	Exact identifier application number: M015
Lidocaine 5%	LIDOCAINE	Apnar Pharma LP	ceedce20-5723-5a9a-e053-2a95a90a17a1	2023-10-21	Warnings	Exact identifier application number: M015
Numquick Topical Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	3f64cbd3-6745-4397-9767-3adc3b301e0e	2023-10-19	Warnings	Exact identifier application number: M015
Healquick Tattoo Balm	PETROLATUM	Unit Dose, Ltd.	96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86	2023-10-19	Warnings	Exact identifier application number: M015
Numpot Topical Anesthetic	LIDOCAINE, PETROLATUM	Unit Dose, Ltd.	9143b50b-7d76-4545-aa2e-1bb77ffb44ae	2023-10-19	Warnings	Exact identifier application number: M015
Microcaine Topical Analgesic	LIDOCAINE	Unit Dose, Ltd.	5e8fa8b5-0524-4201-91e1-83e59a8f0415	2023-10-19	Warnings	Exact identifier application number: M015
Numstick	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	127bbd87-5402-4da2-abf3-dac6367735ec	2023-10-18	Warnings	Exact identifier application number: M015
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminE	HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE	NeilMed pharmaceuticals Inc.	076b5021-8ba0-0204-e063-6294a90a3337	2023-10-11	Warnings	Exact identifier application number: M015
Zensa Numbing Gel	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Alera Skin Care Products Inc.	065a6eec-3896-0da8-e063-6394a90a849d	2023-09-27	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	15
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	15
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2871-04	00573287104	2 CARTON in 1 PACKAGE (0573-2871-04) / 1 TUBE in 1 CARTON / 57 g in 1 TUBE	2 carton	2004-03-01	0000-00-00	No	No	Current
0573-2871-10	00573287110	1 TUBE in 1 CARTON (0573-2871-10) / 28 g in 1 TUBE	1 tube	2004-03-01	0000-00-00	No	No	Current
0573-2871-20	00573287120	1 TUBE in 1 CARTON (0573-2871-20) / 57 g in 1 TUBE	1 tube	2004-03-01	0000-00-00	No	No	Current
0573-2871-91	00573287191	1 TUBE in 1 CARTON (0573-2871-91) / 28 g in 1 TUBE	1 tube	2018-03-01	0000-00-00	No	No	Current
0573-2871-92	00573287192	1 TUBE in 1 CARTON (0573-2871-92) / 57 g in 1 TUBE	1 tube	2018-03-01	0000-00-00	No	No	Current
0573-2871-93	00573287193	1 TUBE in 1 CARTON (0573-2871-93) / 28 g in 1 TUBE	1 tube	2019-06-01	0000-00-00	No	No	Current
0573-2871-94	00573287194	1 TUBE in 1 CARTON (0573-2871-94) / 57 g in 1 TUBE	1 tube	2020-05-17	0000-00-00	No	No	Current