Calcium

Product NDC: 42248-104
11-digit product format: 422480104
Labeler code: 42248
Product ID: 42248-104_b769397d-8e80-4d92-9e25-60301a2b4f54
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Zenith Medicosm SL
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-08-15
Marketing end: 0000-00-00
Substance: OCTINOXATE
Active strength: 4 mL/50mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42248-104		I	Inactivated by FDA		2026-10-05
excluded package	package	42248-104	42248-104-02	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	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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`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	42248-104-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42248-104-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42248-104-02	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42248-104-02	`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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42248-104-02	2019-11-13	C162847	48780-1	97449f38-ce4e-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42248-104-02	CalciumRepair	1 in 1 BOX	CREAM	1		4
42248-104-02	CalciumRepair	50 mL in 1 JAR	CREAM	50		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
CALCIUM GLUCONATE	INACTIVE INGREDIENT	SQE6VB453K	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
COLLAGEN, SOLUBLE, FISH SKIN	INACTIVE INGREDIENT	8JC99XGU4W	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
FUCUS VESICULOSUS	INACTIVE INGREDIENT	535G2ABX9M	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PANAX GINSENG FRUIT	INACTIVE INGREDIENT	E35T4MOI3E	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PEG-32 STEARATE	INACTIVE INGREDIENT	33GX5WQC0M	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PEG-6 STEARATE	INACTIVE INGREDIENT	8LQC57C6B0	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
ROSA MOSCHATA OIL	INACTIVE INGREDIENT	J99W255AWF	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
SOY ISOFLAVONES	INACTIVE INGREDIENT	71B37NR06D	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42248-104	CALCIUM REPAIR (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4	Legacy NDC, 2 package rows	20120123_f518bd48-fb0f-4d92-a793-2074000f95dc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42248-104-02	42248010402	1 in 1 BOX	Historical