TheraPlus

Product NDC: 55621-005
11-digit product format: 556210005
Labeler code: 55621
Product ID: 55621-005_0884a753-f425-506b-e063-6394a90ac93e
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCI
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-03-01
Substance: PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM
Active strength: .25; 14; 74.9 g/100g; g/100g; g/100g
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: TheraPlus
Brand name suffix: Plus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g
MINERAL OIL	14 g/100g
PETROLATUM	74.9 g/100g

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
edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55621-005-01	TheraPlus Plus	42 g in 1 TUBE	OINTMENT	42		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55621-005	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	5	Current NDC, Legacy NDC, 1 package rows	20231025_edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Preparation H Cooling Gel	PHENYLEPHRINE HCL, WITCH HAZEL	Haleon US Holdings LLC	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier application number: M015
Preparation H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL	Haleon US Holdings LLC	2f370875-0225-47b7-b43f-8fa4600d2a0e	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a23ded81-78ba-c199-a8f0-aaf360b216ff	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H MEDICATED WIPES	WITCH HAZEL	Haleon US Holdings LLC	3b1cfa8a-942f-471e-b7c0-744f83b687a0	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Exact identifier application number: M015
PREPARATION H	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Haleon US Holdings LLC	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	27db1d58-4609-4a80-af2f-9e36f10482e1	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier application number: M015
Numquick Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	b66e7a91-9e35-64dd-e053-2a95a90a8b83	2024-02-28	Warnings	Exact identifier application number: M015
Medicated Wipes Hemorroidal Wipes With Witch Hazel	WITCH HAZEL	Wuhan Zonsen Medical Products Co., Ltd.	12441e46-5490-d45c-e063-6394a90a39e3	2024-02-26	Warnings	Exact identifier application number: M015
Lidocaine Hemorrhoid	LIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZEL	Walgreens Co	10a47899-f4a0-66e8-e063-6394a90a11dd	2024-02-05	Warnings	Exact identifier application number: M015
ER Hemorrhoid	PHENYLEPHRINE HCL	EVER READY FIRST AID	3cf29fc0-af4d-4610-a426-894601d5e078	2024-02-02	Warnings	Exact identifier application number: M015
RRHOID RAGE Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	a02a6398-0acd-4aa7-8320-ac586ff12eb3	2024-01-31	Warnings	Exact identifier application number: M015
No More Products	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc	102e7dbb-06dc-f4d1-e063-6394a90aa3eb	2024-01-26	Warnings	Exact identifier application number: M015
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc.	0fe10710-ac59-4fc5-e063-6294a90a48fc	2024-01-26	Warnings	Exact identifier application number: M015
Prosoria Anti-Itch Moisturizer	PRAMOXINE HYDROCHLORIDE	Nuvothera, Inc.	3c4b9515-f435-4227-a347-d6508778426d	2024-01-10	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Cardinal Health 110 dba LEADER	a5a261c2-1f36-c895-e053-2a95a90ab22b	2024-01-02	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Proficient Rx LP	105095e3-843e-4153-adc9-266dd14929a2	2024-01-01	Warnings	Exact identifier application number: M015
Family Wellness HEMORRHOID	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	FAMILY DOLLAR (Family Wellness)	16ceb129-5c0a-428a-a867-cfbbb08bb62a	2023-12-11	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	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	5
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	5
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55621-005-01	55621000501	42 g in 1 TUBE (55621-005-01)	42 g	2013-03-01	0000-00-00	No	No	Current