Spai-Sons

Product NDC: 66854-001
11-digit product format: 668540001
Labeler code: 66854
Product ID: 66854-001_d5e0b1f7-aecb-40d6-b2ea-41257b43cc5f
Type: HUMAN OTC DRUG
Nonproprietary name: Calendula Officinalis Flower Extract
Dosage form: CREAM
Route: TOPICAL
Labeler: SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-06-01
Marketing end: 0000-00-00
Substance: CALENDULA OFFICINALIS FLOWER; SULFUR
Active strength: 20 g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66854-001		I	Inactivated by FDA	2026-10-05
excluded package	package	66854-001	66854-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	66854-001	66854-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	66854-001	66854-001-05	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 2 · 88 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	66854-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-001-01	`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	66854-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-001-01	`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	66854-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-001-01	`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	66854-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-001-01	`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	66854-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-001-01	`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	66854-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-001-01	`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	66854-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-001-01	`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	66854-001-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-001-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-001-01	`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	66854-001-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-001-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-001-01	`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	66854-001-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-001-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-001-01	`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	66854-001-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-001-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-001-01	`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	66854-001-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-001-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-001-01	`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	66854-001-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-001-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-001-01	`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	66854-001-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-001-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-001-01	`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	66854-001-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-001-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-001-01	`1332a3947898…`	`d4bfe170f9cd…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-001-01	2019-11-13	C162847	48780-1	97449f38-c43a-f6ea-e053-dbdaa90aa703	SPAI-SONS MARIGOLD CREAM / CREMA DE CALENDULA
66854-001-03	2019-11-13	C162847	48780-1	97449f38-c43a-f6ea-e053-dbdaa90aa703	SPAI-SONS MARIGOLD CREAM / CREMA DE CALENDULA
66854-001-05	2019-11-13	C162847	48780-1	97449f38-c43a-f6ea-e053-dbdaa90aa703	SPAI-SONS MARIGOLD CREAM / CREMA DE CALENDULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-001-01	Spai-SonsCalendula/Marigold	9 g in 1 JAR	CREAM	9	1
66854-001-02	Spai-SonsCalendula/Marigold	33 g in 1 JAR	CREAM	33	1
66854-001-03	Spai-SonsCalendula/Marigold	1 in 1 BOX	CREAM	1	1
66854-001-04	Spai-SonsCalendula/Marigold	60 g in 1 JAR	CREAM	60	1
66854-001-05	Spai-SonsCalendula/Marigold	1 in 1 BOX	CREAM	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALENDULA OFFICINALIS FLOWER	ACTIVE INGREDIENT	P0M7O4Y7YD	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CALENDULA OFFICINALIS FLOWER	ACTIVE MOIETY	P0M7O4Y7YD	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
HAMAMELIS VIRGINIANA TOP	INACTIVE INGREDIENT	UDA30A2JJY	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-001	SPAI-SONS CALENDULA/MARIGOLD (CALENDULA OFFICINALIS FLOWER EXTRACT) CREAM [SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 5 package rows	20120426_92f6d96f-d7cd-4588-ae02-b86ca984e23e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P0M7O4Y7YD	CALENDULA OFFICINALIS FLOWER		CALENDULA OFFICINALIS FLOWER
70FD1KFU70	SULFUR	7704-34-9	SULFUR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66854-001-01	66854000101	9 g in 1 JAR	9 g	Historical
66854-001-02	66854000102	33 g in 1 JAR	33 g	Historical
66854-001-03	66854000103	1 in 1 BOX		Historical
66854-001-04	66854000104	60 g in 1 JAR	60 g	Historical
66854-001-05	66854000105	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPAI-SONS MARIGOLD CREAM / CREMA DE CALENDULA	SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS	2012-04-25	HUMAN OTC DRUG LABEL	1