FDA.reportPublic FDA data

BABY MUCUS PLUS COLD RELIEF

Product NDC
54973-3284
Requested package NDC
54973-3284-1
11-digit product format
549733284
Labeler code
54973
Product ID
54973-3284_0384ed1c-8da1-f57c-e063-6394a90ad016
Type
HUMAN OTC DRUG
Nonproprietary name
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-05-13
Substance
BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SILICON DIOXIDE; RUMEX CRISPUS ROOT
Active strength
6; 6; 12; 30; 30; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
BABY MUCUS PLUS COLD RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRYONIA ALBA ROOT6 [hp_X]/mL
EUPHRASIA STRICTA6 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
SODIUM CHLORIDE30 [hp_X]/mL
PHOSPHORUS30 [hp_X]/mL
ANEMONE PULSATILLA6 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
RUMEX CRISPUS ROOT6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T7J046YI2BInternal UNII lookup
C9642I91WLInternal UNII lookup
1MBW07J51QInternal UNII lookup
451W47IQ8XInternal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
9N1RM2S62CInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d934cc8a-1e43-4942-858a-05b5d068679aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3284-1BABY MUCUS PLUS COLD RELIEF118 mL in 1 BOTTLE, PLASTICLIQUID11812
54973-3284-1BABY MUCUS PLUS COLD RELIEF1 in 1 CARTONLIQUID112
54973-3284-2BABY MUCUS PLUS COLD RELIEF2.5 mL in 1 POUCHLIQUID2.512
54973-3284-3BABY MUCUS PLUS COLD RELIEF148 mL in 1 BOTTLE, PLASTICLIQUID14812
54973-3284-3BABY MUCUS PLUS COLD RELIEF1 in 1 CARTONLIQUID112
54973-3284-1BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3284BABY MUCUS PLUS COLD RELIEF (BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE) LIQUID [HYLAND'S INC.]12Current NDC, Legacy NDC, 5 package rows20230823_d934cc8a-1e43-4942-858a-05b5d068679a.zip
54973-3284BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIMECALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.7979fc6f-6d2c-56c9-e053-2991aa0ac1f32023-08-23WarningsExact identifier
ndc (package): 54973-3284-1
ndc11 (package): 54973328401
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
ndc (package): 54973-3284-1
ndc (product): 54973-3284
ndc11 (package): 54973328401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3284-1549733284011 BOTTLE, PLASTIC in 1 CARTON (54973-3284-1) / 118 mL in 1 BOTTLE, PLASTIC2016-05-130000-00-00NoNoCurrent