Dr. Fibra

Product NDC
55758-418
11-digit product format
557580418
Labeler code
55758
Product ID
55758-418_1ddc7cb3-05e6-6453-e063-6294a90a620a
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
POWDER
Route
ORAL
Labeler
Pharmadel LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-30
Substance
PSYLLIUM HUSK
Active strength
3.4 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dr. Fibra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK3.4 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0SHO53407G
Rxcui824586

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-418-10Dr. Fibra10 in 1 BOXPOWDER102
55758-418-10Dr. Fibra1 in 1 PACKETPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-418DR. FIBRA (PSYLLIUM HUSK) POWDER [PHARMADEL LLC]2Current NDC, 2 package rows20240724_1a6151c9-e1c4-f0c1-e063-6394a90aad24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN1a6151c9-e1c4-f0c1-e063-6394a90aad242
824586psyllium 3400 MG Powder for Oral SuspensionSCD1a6151c9-e1c4-f0c1-e063-6394a90aad242
824586psyllium 3.4 GM Powder for Oral SuspensionSY1a6151c9-e1c4-f0c1-e063-6394a90aad242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-418-105575804181010 PACKET in 1 BOX (55758-418-10) / 1 POWDER in 1 PACKET10 packet2024-06-30NoNoHistorical