THEA SINENSIS

Product NDC: 15631-0438
11-digit product format: 156310438
Labeler code: 15631
Product ID: 15631-0438_a1d0bf28-e471-5abd-e053-2a95a90a1187
Type: HUMAN OTC DRUG
Nonproprietary name: THEA SINENSIS
Dosage form: PELLET
Route: ORAL
Labeler: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2015-11-02
Marketing end: 0000-00-00
Substance: GREEN TEA LEAF
Active strength: 1 [hp_X]/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	15631-0438		I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-0	I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-1	I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-2	I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-3	I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-4	I	Inactivated by FDA	2026-10-05
excluded package	package	15631-0438	15631-0438-5	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 3 · 133 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15631-0438-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15631-0438-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15631-0438-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15631-0438-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15631-0438-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15631-0438-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15631-0438-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15631-0438-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15631-0438-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15631-0438-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15631-0438-5	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
15631-0438-0	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-1	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-2	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-3	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-4	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-5	2022-01-28	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-0	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-1	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-2	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-3	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-4	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-5	2020-03-27	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-0	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-1	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-2	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-3	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-4	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1
15631-0438-5	2020-01-31	03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15631-0438-0	THEA SINENSIS	100 in 1 VIAL, SINGLE-DOSE	PELLET	100	2
15631-0438-1	THEA SINENSIS	200 in 1 PACKAGE	PELLET	200	2
15631-0438-2	THEA SINENSIS	400 in 1 PACKAGE	PELLET	400	2
15631-0438-3	THEA SINENSIS	750 in 1 PACKAGE	PELLET	750	2
15631-0438-4	THEA SINENSIS	2500 in 1 PACKAGE	PELLET	2500	2
15631-0438-5	THEA SINENSIS	12500 in 1 PACKAGE	PELLET	12500	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GREEN TEA LEAF	ACTIVE INGREDIENT	W2ZU1RY8B0	THEA SINENSIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	1
GREEN TEA LEAF	ACTIVE MOIETY	W2ZU1RY8B0	THEA SINENSIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	THEA SINENSIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15631-0438	THEA SINENSIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	2	Legacy NDC, 6 package rows	20200330_03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
W2ZU1RY8B0	GREEN TEA LEAF	GREEN TEA LEAF

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
15631-0438-0	15631043800	100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0438-0)	100 pellet	2018-01-01	0000-00-00	No	No	Current
15631-0438-1	15631043801	200 PELLET in 1 PACKAGE (15631-0438-1)	200 pellet	2018-01-01	0000-00-00	No	No	Current
15631-0438-2	15631043802	400 PELLET in 1 PACKAGE (15631-0438-2)	400 pellet	2018-01-01	0000-00-00	No	No	Current
15631-0438-3	15631043803	750 PELLET in 1 PACKAGE (15631-0438-3)	750 pellet	2018-01-01	0000-00-00	No	No	Current
15631-0438-4	15631043804	2500 PELLET in 1 PACKAGE (15631-0438-4)	2500 pellet	2018-01-01	0000-00-00	No	No	Current
15631-0438-5	15631043805	12500 PELLET in 1 PACKAGE (15631-0438-5)	12500 pellet	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THEA SINENSIS - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	2020-03-27	HUMAN OTC DRUG LABEL	2