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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Rapid Relief Hemorrhoidal	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	00eef84c-a72e-3343-e063-6294a90aa4d8	2024-12-19	Warnings	Exact identifier application number: M015
Formula 2 Skin Care	LIDOCAINE 5%	Derma Care Research Labs	a05d5e07-ae4b-38cc-e053-2a95a90abced	2024-12-19	Warnings	Exact identifier application number: M015
Revivol Hemorrhoid and Fissure	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0140cf68-b6a0-4378-e063-6394a90afee8	2024-12-19	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Trifecta Pharmaceuticals Usa Llc	651c0143-384c-3649-e053-2991aa0a0f28	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c50cc6ad-e8a0-47c1-e053-2a95a90a4de6	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	fe18fa61-83f9-8bf9-e053-6294a90a7585	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c59dcb2a-392b-670b-e053-2995a90a9682	2024-12-18	Warnings	Exact identifier application number: M015
TheraCare Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Veridian Healthcare	fab95657-d257-e671-e053-6294a90a59e0	2024-12-18	Warnings	Exact identifier application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal Pads	WITCH HAZEL	Dickinson Brands Inc.	1b50f4dc-c26a-431a-ae18-c43513871b39	2024-12-18	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Exact identifier application number: M015
Recticare Advanced	LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM	Ferndale Laboratories, Inc.	209212a7-7b6e-4b26-9f31-0eeb76f026bf	2024-12-17	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE AND GLYCERIN	Ferndale Laboratories, Inc.	2b94136a-4975-2925-e054-00144ff88e88	2024-12-17	Warnings	Exact identifier application number: M015
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Rugby	a5b5e0a9-eee9-2a1e-e053-2a95a90a464e	2024-12-17	Warnings	Exact identifier application number: M015
Warrior Rectal Care	LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	fc10cbc3-fc1b-ae09-e053-6394a90ac8f3	2024-12-15	Warnings	Exact identifier application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)	GLYCERIN, LIDOCAINE, AND WITCH HAZEL	Blistex Inc	a7cb6d78-3048-43b3-afe7-4d862fdcfd3f	2024-12-13	Warnings	Exact identifier application number: M015
Tucks Medicated Cooling Pads	WITCH HAZEL	Blistex Inc	b3e68008-3d0d-4124-9579-b503e9fb95c9	2024-12-13	Warnings	Exact identifier application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	2a4273a4-3bda-4653-a065-cd4578053f3c	2024-12-12	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Medical Products Laboratories, Inc.	b815792f-2f8f-7ac8-e053-2995a90ade18	2024-12-11	Warnings	Exact identifier application number: M015
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	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