Calmicid AC

Product NDC: 54473-411
11-digit product format: 544730411
Labeler code: 54473
Product ID: 54473-411_369ae213-cd24-57ba-e063-6394a90a87a6
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Melaleuca, Inc.
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-20
Substance: FAMOTIDINE
Active strength: 20 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 54473-411_369ae213-cd24-57ba-e063-6394a90a87a6
SPL ID: 369ae213-cd24-57ba-e063-6394a90a87a6
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: Calmicid AC
Brand name suffix: Acid Reducer
Generic name: Famotidine
Dosage form: TABLET, COATED
Route: ORAL
Marketing start: 2011-01-20
Marketing category: OTC MONOGRAPH DRUG
Application number: M001
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA]; Histamine-2 Receptor Antagonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
FAMOTIDINE	20 mg/1

Package NDC	Description	Marketing start	Sample
54473-411-01	1 BOTTLE in 1 BOX (54473-411-01) / 50 TABLET, COATED in 1 BOTTLE (54473-411-50)	2018-01-20	No

UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54473-411-01	54473041101	1 BOTTLE in 1 BOX (54473-411-01) / 50 TABLET, COATED in 1 BOTTLE (54473-411-50)	1 bottle	2018-01-20	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Calmicid AC	Melaleuca, Inc.	2025-06-02	HUMAN OTC DRUG LABEL	1