Red Serum

Product NDC: 69457-000
11-digit product format: 694570000
Labeler code: 69457
Product ID: 69457-000_4506bc04-758a-4f66-b4a1-27fa2c73ace3
Type: HUMAN OTC DRUG
Nonproprietary name: Witch Hazel
Dosage form: GEL
Route: TOPICAL
Labeler: LAB & Company Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-03-18
Marketing end: 0000-00-00
Substance: WITCH HAZEL
Active strength: 3 g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69457-000		I	Inactivated by FDA		2026-10-05
excluded package	package	69457-000	69457-000-00	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69457-000-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69457-000-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69457-000-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69457-000-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69457-000-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69457-000-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69457-000-00	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69457-000-00	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69457-000-00	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69457-000-00	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69457-000-00	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69457-000-00	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69457-000-00	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69457-000-00	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69457-000-00	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69457-000-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69457-000-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69457-000-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69457-000-00	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69457-000-00	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69457-000-00	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69457-000-00	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69457-000-00	2020-01-31	C162847	48780-1	9d75b9cf-d6e2-f424-e053-dadaa90a57ce	0d6098ef-910f-4b2b-a147-e152b1141c72

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69457-000-00	Red Serum	40 g in 1 PACKAGE	GEL	40		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
BETAINE	INACTIVE INGREDIENT	3SCV180C9W	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
BOSWELLIA SERRATA RESIN OIL	INACTIVE INGREDIENT	5T1XCE6K8K	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
CAPRYLHYDROXAMIC ACID	INACTIVE INGREDIENT	UPY805K99W	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
DIOSCOREA OPPOSITIFOLIA WHOLE	INACTIVE INGREDIENT	KZY1A7K8MD	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
EUTERPE OLERACEA WHOLE	INACTIVE INGREDIENT	Y57H6218HP	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
JASMINUM OFFICINALE WHOLE	INACTIVE INGREDIENT	X3314B4SYD	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
LEPIDIUM SATIVUM LEAF	INACTIVE INGREDIENT	2ML4POY35W	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
LYCIUM CHINENSE FRUIT	INACTIVE INGREDIENT	TG711Q7A1Q	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
PEG-60 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	02NG325BQG	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
PUNICA GRANATUM WHOLE	INACTIVE INGREDIENT	O2ZTS50U5E	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
RUBUS CHAMAEMORUS FRUIT	INACTIVE INGREDIENT	74CW8G72Q6	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
RUBUS IDAEUS FRUIT VOLATILE OIL	INACTIVE INGREDIENT	276X2YNL0K	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
VACCINIUM ANGUSTIFOLIUM WHOLE	INACTIVE INGREDIENT	R3538BZ1BW	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69457-000	RED SERUM (WITCH HAZEL) GEL [LAB & COMPANY INC.]	1	Legacy NDC, 1 package rows	20150318_0d6098ef-910f-4b2b-a147-e152b1141c72.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69457-000-00	69457000000	40 g in 1 PACKAGE	40 g	Historical