Calm

Product NDC
54973-3331
Requested package NDC
54973-3331-1
11-digit product format
549733331
Labeler code
54973
Product ID
54973-3331_ece9634b-2aa1-52fd-e053-2995a90aef51
Type
HUMAN OTC DRUG
Nonproprietary name
TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-12-04
Marketing end
0000-00-00
Substance
DIBASIC POTASSIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54973-333154973-3331-1DDiscontinued by firm2026-10-05

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 conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3331-1Calm50 in 1 BOTTLE, PLASTICTABLET505
54973-3331-1Calm1 in 1 CARTONTABLET15
54973-3331-2Calm4 in 1 POUCHTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3331CALM (TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET [HYLAND'S INC.]5Legacy NDC, 3 package rows20250322_5e86783c-4154-5f46-e053-2991aa0abb3b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalmTRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHyland's Inc.5e86783c-4154-5f46-e053-2991aa0abb3b2025-03-19WarningsExact identifier
ndc (package): 54973-3331-1
ndc (product): 54973-3331
ndc11 (package): 54973333101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3331-1549733331011 BOTTLE, PLASTIC in 1 CARTON (54973-3331-1) > 50 TABLET in 1 BOTTLE, PLASTIC2017-12-040000-00-00NoNoCurrent