FDA.reportPublic FDA data

Valerin

Product NDC
99528-606
11-digit product format
995280606
Labeler code
99528
Product ID
99528-606_2b0cae62-a2f6-2fa2-e063-6394a90a5d19
Type
HUMAN OTC DRUG
Nonproprietary name
Valerian Root, Passiflora, Magnesium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Wonder Laboratories
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1986-06-12
Substance
MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWER; VALERIAN
Active strength
1; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valerin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM CARBONATE1 [hp_X]/1
PASSIFLORA INCARNATA FLOWER3 [hp_X]/1
VALERIAN6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E53J927NA, K8F3G29S6Z, JWF5YAW3QW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
99528-606-06Valerin6 in 1 BAGTABLET66
99528-606-12Valerin12 in 1 BAGTABLET126
99528-606-25Valerin250 in 1 BOTTLETABLET2506
99528-606-45Valerin45 in 1 BOTTLETABLET456
99528-606-90Valerin90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
MentholACTIVE MOIETYL7T10EIP3AKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ETKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302KOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3KOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4KOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1
WaterINACTIVE INGREDIENT059QF0KO0RKOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99528-606VALERIN (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [WONDER LABORATORIES]6Current NDC, Legacy NDC, 5 package rows20250108_78d151c5-b7b1-424f-9fea-5c562de1e147.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99528-606-06995280606066 TABLET in 1 BAG (99528-606-06) 6 tablet1986-06-120000-00-00NoNoCurrent
99528-606-129952806061212 TABLET in 1 BAG (99528-606-12) 12 tablet2017-06-010000-00-00YesNoCurrent
99528-606-2599528060625250 TABLET in 1 BOTTLE (99528-606-25) 250 tablet1986-06-120000-00-00NoNoCurrent
99528-606-459952806064545 TABLET in 1 BOTTLE (99528-606-45) 45 tablet2019-11-010000-00-00NoNoCurrent
99528-606-909952806069090 TABLET in 1 BOTTLE (99528-606-90) 90 tablet1986-06-120000-00-00NoNoCurrent