Mae by Damiva

Product NDC: 69316-321
11-digit product format: 693160321
Labeler code: 69316
Product ID: 69316-321_6031b8e2-9ac0-4b83-b870-d8d0c9c8d7b3
Type: HUMAN OTC DRUG
Nonproprietary name: Calendula and Hamamelis
Dosage form: SUPPOSITORY
Route: VAGINAL
Labeler: Damiva Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2014-11-10
Marketing end: 0000-00-00
Substance: CALENDULA OFFICINALIS FLOWER; HAMAMELIS VIRGINIANA LEAF
Active strength: 1 [hp_X]/1; [hp_X]/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69316-321		I	Inactivated by FDA		2026-10-20
excluded package	package	69316-321	69316-321-10	I	Inactivated by FDA		2026-10-20

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 · 38 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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`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	69316-321-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69316-321-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69316-321-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69316-321-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69316-321-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69316-321-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69316-321-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69316-321-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69316-321-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69316-321-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69316-321-10	`8dfbde2a14a4…`	`c9ff85d89658…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69316-321-10	2021-01-29	C162847	48780-1	ba0f9c33-4275-a910-e053-dadaa90a0b85	Mae by Damiva

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69316-321-10	Mae by Damiva	10 in 1 BOX	SUPPOSITORY	10		5
69316-321-10	Mae by Damiva	1 in 1 CELLO PACK	SUPPOSITORY	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALENDULA OFFICINALIS FLOWER	ACTIVE INGREDIENT	P0M7O4Y7YD	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
HAMAMELIS VIRGINIANA LEAF	ACTIVE INGREDIENT	T07U1161SV	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
CALENDULA OFFICINALIS FLOWER	ACTIVE MOIETY	P0M7O4Y7YD	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
HAMAMELIS VIRGINIANA LEAF	ACTIVE MOIETY	T07U1161SV	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
GARCINIA INDICA SEED BUTTER	INACTIVE INGREDIENT	US2H3D7800	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69316-321	MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]	5	Legacy NDC, 2 package rows	20190101_7f4a11c3-95bf-419b-8460-ea9d946fc724.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
P0M7O4Y7YD	CALENDULA OFFICINALIS FLOWER	CALENDULA OFFICINALIS FLOWER
T07U1161SV	HAMAMELIS VIRGINIANA LEAF	HAMAMELIS VIRGINIANA LEAF

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69316-321-10	69316032110	10 in 1 BOX	Historical