PURA

Product NDC: 84217-050
11-digit product format: 842170050
Labeler code: 84217
Product ID: 84217-050_453a5aea-e8d8-e6f9-e063-6294a90a9ad9
Type: HUMAN OTC DRUG
Nonproprietary name: Witch Hazel
Dosage form: CLOTH
Route: TOPICAL
Labeler: Mypura.com Limited
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-02
Substance: WITCH HAZEL
Active strength: 50 mg/1
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: PURA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WITCH HAZEL	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
101I4J0U34	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
844379	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
1523f52f-6a5b-a12d-e063-6294a90a4496	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84217-050-48	PURA	48 in 1 BOX	CLOTH	48		3
84217-050-48	PURA	1 in 1 PATCH	CLOTH	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84217-050	PURA (WITCH HAZEL) CLOTH [MYPURA.COM LIMITED]	2	Current NDC, 2 package rows	20241218_1523f52f-6a5b-a12d-e063-6294a90a4496.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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mayinglong Hemorrhoidal	PETROLATUM, ZINC OXIDE	Mayinglong Pharmaceutical Group Co., Ltd.	b14192ea-1bf7-da6a-e053-2a95a90a5b5e	2023-12-08	Warnings	Exact identifier application number: M015
Hemorrhoidal cooling gel	PHENYLEPHRINE HCL, WITCH HAZEL	WALGREENS	03bbe258-e00d-13cc-e063-6394a90ae345	2023-12-05	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	WALGREENS	03bc5c1a-d493-5082-e063-6394a90ae87b	2023-12-05	Warnings	Exact identifier application number: M015
Bloop Hemorrhoid Relief Topical	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Three Nations Corp	0b6419e3-f1c7-bdfe-e063-6294a90a5d92	2023-11-30	Warnings	Exact identifier application number: M015
Bloop Fissure Healing Anorectal Topical	LIDOCAINE	Three Nations Corp	0b645092-ebc4-e4bb-e063-6294a90ad4cf	2023-11-30	Warnings	Exact identifier application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF	LIDOCAINE	ALPHA PLANTS INC	79fa4b89-382f-45fa-a792-90a9fe5bf573	2023-11-11	Warnings	Exact identifier application number: M015
BODY ACTION PRODUCTS Prolong Lubricating	BENZOCAINE	PRODUCT MAX GROUP INC	3bef5915-1c98-4011-baa9-ad0bbef200c2	2023-11-10	Warnings	Exact identifier application number: M015
BODY ACTION PRODUCTS Butt Eze Benzocaine	BENZOCAINE	PRODUCT MAX GROUP INC	ba75b129-7939-4373-91f5-1772976e6d61	2023-11-10	Warnings	Exact identifier application number: M015
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	441c802f-a363-1530-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M015
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	4939a547-c94b-3350-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M015
DR REAL NUMB Topical Anorectal	LIDOCAINE	FUZZYLULU LLC	378d8edc-2120-416d-854c-8881c2950efe	2023-11-09	Warnings	Exact identifier application number: M015
The Pharma C Company Medicated Foam with Witch Hazel	WITCH HAZEL	Kleen Test Products Corporation	1a1fbe83-be45-4654-a7bb-e934e1ccd0c6	2023-11-09	Warnings	Exact identifier application number: M015
The Pharma-C Company Medicated Hemorrhoidal Pads	WITCH HAZEL	Kleen Test Products Corporation	357703ab-4e7a-41f6-9ecf-aa98acc2d92e	2023-11-09	Warnings	Exact identifier application number: M015
DOCTORS TOUCH Erase The Pain Lidocaine	LIDOCAINE HYDROCHLORIDE	DOCTOR'S CHOICE MEDICAL, LLC	3dc9947b-8196-4a38-97b4-c2340ee77e0f	2023-11-06	Warnings	Exact identifier application number: M015
SCALAR Pain Relief Cream	MENTHOL	Miracle Balance, LLC	52a13cfe-3f46-45f8-a5af-ce07ea5758e3	2023-11-06	Warnings	Exact identifier application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief Cream	PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	SIMPLE PROMISE PTE LTD	f6622caa-3b31-9b07-e053-2a95a90a8a51	2023-11-06	Warnings	Exact identifier application number: M015
WAXUP Numbing	LIDOCAINE HYDROCHLORIDE	CONSTRUSOLUTION, LLC	4f1645ab-1b19-4d69-99c3-9ea275b01a87	2023-11-06	Warnings	Exact identifier application number: M015
SECONDARY NUMB Lidocaine Phenylephrine Gel	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	LALANI Rx Consulting, Inc.	0f13f7b5-e3b1-451e-a6d6-e7e15bd04443	2023-11-06	Warnings	Exact identifier application number: M015
Brazzers Anal Desensitizing	LIDOCAINE	Metro Media Ent	ceacd80c-0dd6-4e21-97da-56da877b1c90	2023-11-06	Warnings	Exact identifier application number: M015
NUMB PLUS Maximum Strength Anorectal	LIDOCAINE	SEENEXT VENTURE LTD	a7c37b2a-b647-43d7-b43b-87bbece35430	2023-11-05	Warnings	Exact identifier application number: M015

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
101I4J0U34	WITCH HAZEL	WITCH HAZEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
844379	witch hazel 50 % Medicated Pad	PSN	1523f52f-6a5b-a12d-e063-6294a90a4496	3
844379	witch hazel 500 MG/ML Medicated Pad	SCD	1523f52f-6a5b-a12d-e063-6294a90a4496	3
844379	witch hazel 50 % Medicated Pad	SY	1523f52f-6a5b-a12d-e063-6294a90a4496	3
844379	witch hazel 50 % Medicated Wipes	SY	1523f52f-6a5b-a12d-e063-6294a90a4496	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84217-050-48	84217005048	48 PATCH in 1 BOX (84217-050-48) / 1 CLOTH in 1 PATCH	48 patch	2024-04-02	No	No	Current