D-121

Product NDC: 58264-0127
Requested package NDC: 58264-0127-1
11-digit product format: 582640127
Labeler code: 58264
Product ID: 58264-0127_2b9ed994-a88c-0e65-e063-6394a90aca84
Type: HUMAN OTC DRUG
Nonproprietary name: Calcium Fluoride
Dosage form: SOLUTION
Route: SUBLINGUAL
Labeler: DNA Labs, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 1990-01-01
Substance: CALCIUM FLUORIDE
Active strength: 8 [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Additional Listing Data#

Finished product: Yes
Brand name base: D-121
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM FLUORIDE	8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O3B55K4YKI	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5495bfae-4080-4506-b16e-0c777faabcbb	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58264-0127-1	2022-06-06	C162847	48780-1	9d75b9d1-1227-f424-e053-dadaa90a57ce	D-121
58264-0127-1	2020-01-31	C162847	48780-1	9d75b9d1-1227-f424-e053-dadaa90a57ce	D-121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58264-0127-1	D-121	29.57 mL in 1 BOTTLE, GLASS	SOLUTION	29.57		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58264-0127	D-121 (CALCIUM FLUORIDE) SOLUTION [DNA LABS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250115_5495bfae-4080-4506-b16e-0c777faabcbb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
D-121	CALCIUM FLUORIDE	DNA Labs, Inc.	5495bfae-4080-4506-b16e-0c777faabcbb	2025-01-13	Warnings	Exact identifier ndc (package): 58264-0127-1 ndc (product): 58264-0127 ndc11 (package): 58264012701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O3B55K4YKI	CALCIUM FLUORIDE	7789-75-5	CALCIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58264-0127-1	58264012701	29.57 mL in 1 BOTTLE, GLASS (58264-0127-1)	29.57 ml	1990-01-01	0000-00-00	No	No	Current