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 15 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Anal Glide Extra	BENZOCAINE	PRODUCT MAX GROUP INC	282ac8d3-2caf-42de-b347-450e9c7a9e50	2025-04-03	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	984c4bee-0d44-4e0f-a057-0d54400c4cac	2025-04-02	Warnings	Exact identifier application number: M015
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bionpharma Inc.	1790da99-2a22-e2a2-e063-6394a90ac36f	2025-03-31	Warnings	Exact identifier application number: M015
HemAway	LIDOCAINE	Melaleuca, Inc.	cf842adf-fcd7-2c8c-e053-2995a90adea6	2025-03-27	Warnings	Exact identifier application number: M015
Numb and Number Anorectal Cream	LIDOCAINE	Dermtech Labs, Inc	31420635-5021-173d-e063-6294a90a407a	2025-03-26	Warnings	Exact identifier application number: M015
Leader Maximum Strength Hemorrhoidal Relief	LIDOCAINE	Cardinal Health,Inc.	65c780b0-7f47-4ae9-a847-c22deaaa2888	2025-03-21	Warnings	Exact identifier application number: M015
Curist Hemorrhoid Fissure Relief	LIDOCAINE	Little Pharma, Inc	2fb02b00-acdb-5184-e063-6294a90ae1c8	2025-03-06	Warnings	Exact identifier application number: M015
Thera Plus Hemorrhoidal	GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	FOURSTAR GROUP USA, INC.	87143a7a-7b2d-4b67-afda-2355697e7300	2025-03-04	Warnings	Exact identifier application number: M015
Numbskin Maximum Strength Pain Reliever	LIDOCAINE	Shinpharma Inc	2f288bde-99fd-42f8-e063-6394a90a0f05	2025-02-27	Warnings	Exact identifier application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPES	WITCH HAZEL	Haleon US Holdings LLC	1953ec64-20ce-488b-8f14-44e15cc9e720	2025-02-21	Warnings	Exact identifier application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief Cream	MENTHOL, METHYL SALICYLATE	L'BRI HEALTH AND BEAUTY INC	62e18a37-c0db-4b1e-a6a1-35684cc00e08	2025-01-28	Warnings	Exact identifier application number: M015
Hemorrhoidal	PAIN RELIEF	NeilMed Pharmaceuticals Inc.	038a2cf5-1b72-227b-e063-6394a90a84ad	2025-01-24	Warnings	Exact identifier application number: M015
lidocaine	LIDOCAINE	Nivagen Pharmaceuticals, Inc.	32964ec3-1880-477b-9f71-2222c39106aa	2025-01-23	Warnings	Exact identifier application number: M015
Hemorrhoidal cocoa butter	HEMORRHOIDAL	NeilMed Pharmaceuticals Inc.	03b159b0-b960-b38d-e063-6394a90a9462	2025-01-17	Warnings	Exact identifier application number: M015
Gentle Laxative Bisacodyl	GENTLE LAXATIVE BISACODYL	NeilMed Pharmaceuticals Inc	03b3733a-4d78-149f-e063-6294a90a6518	2025-01-17	Warnings	Exact identifier application number: M015
Glycerin Laxative	GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF	NeilMed Pharmaceuticals Inc.	03b4be69-6488-76be-e063-6394a90a7edf	2025-01-17	Warnings	Exact identifier application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent	WITCH HAZEL	Walgreens Company	209a111b-d169-cb5d-e063-6394a90a33ca	2025-01-15	Warnings	Exact identifier application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel	WITCH HAZEL	Walgreens Company	1e2dcec1-a1fe-71d2-e063-6394a90a9908	2025-01-15	Warnings	Exact identifier application number: M015
AER Pre-moistened Witch Hazel Pad	WITCH HAZEL	Birchwood Laboratories LLC	1cca622f-0a6b-4f35-9355-34c249ee705e	2025-01-14	Warnings	Exact identifier application number: M015
B-SURE Traveler Towelette	B-SURE TRAVELER	Birchwood Laboratories LLC	e1a5da94-6a1a-497b-a737-1c1541bf0404	2025-01-14	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