Relax AM-PM

Product NDC
64175-991
11-digit product format
641750991
Labeler code
64175
Product ID
64175-991_2b0c7469-816a-b341-e063-6294a90a2bcc
Type
HUMAN OTC DRUG
Nonproprietary name
Valerian Root, Passiflora, Magnesium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Foster Regal Laboratories
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-11-16
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
Relax AM-PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALERIAN1 [hp_X]/1
PASSIFLORA INCARNATA FLOWER3 [hp_X]/1
MAGNESIUM CARBONATE6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JWF5YAW3QWInternal UNII lookup
K8F3G29S6ZInternal UNII lookup
0E53J927NAInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea434cd3-e4d5-44c1-a9cf-5d1a45280e90Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64175-991-252023-12-18Relax AM-PM
64175-991-452023-12-18Relax AM-PM
64175-991-902023-12-18Relax AM-PM
64175-991-252023-01-30Relax AM-PM
64175-991-452023-01-30Relax AM-PM
64175-991-902023-01-30Relax AM-PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64175-991-25Relax AM-PM250 in 1 BOTTLETABLET2505
64175-991-45Relax AM-PM45 in 1 BOTTLETABLET455
64175-991-90Relax AM-PM90 in 1 BOTTLETABLET905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NARELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
PASSIFLORA INCARNATA FLOWERACTIVE INGREDIENTK8F3G29S6ZRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
ValerianACTIVE INGREDIENTJWF5YAW3QWRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
MagnesiumACTIVE MOIETYI38ZP9992ARELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
PASSIFLORA INCARNATA FLOWERACTIVE MOIETYK8F3G29S6ZRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
ValerianACTIVE MOIETYJWF5YAW3QWRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2RELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64175-991RELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]5Current NDC, Legacy NDC, 3 package rows20250108_ea434cd3-e4d5-44c1-a9cf-5d1a45280e90.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
Relax AM-PMVALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATEFoster Regal Laboratoriesea434cd3-e4d5-44c1-a9cf-5d1a45280e902025-01-06WarningsExact identifier
ndc (product): 64175-991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64175-991-2564175099125250 TABLET in 1 BOTTLE (64175-991-25) 250 tablet2011-11-160000-00-00NoNoCurrent
64175-991-456417509914545 TABLET in 1 BOTTLE (64175-991-45) 45 tablet2011-11-160000-00-00NoNoCurrent
64175-991-906417509919090 TABLET in 1 BOTTLE (64175-991-90) 90 tablet2011-11-160000-00-00NoNoCurrent