FDA.reportPublic FDA data

Reaphirm Plant Source DHA

Product NDC
0642-3010
11-digit product format
006423010
Labeler code
0642
Product ID
0642-3010_37359587-129b-461f-a82f-b4461eeff080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prenatal Supplement
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Everett Laboratories, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-12-05
Marketing end
0000-00-00
Substance
VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; VITAMIN E; IRON
Active strength
1100 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1
Pharmacologic classes
Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin D [CS],Vitamin D [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
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59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0642-3010-302020-01-31C16284748780-19d75b9d1-080a-f424-e053-dadaa90a57ceProduct Information.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0642-3010-30Reaphirm Plant Source DHA5 in 1 BOXCAPSULE, GELATIN COATED51
0642-3010-30Reaphirm Plant Source DHA6 in 1 BLISTER PACKCAPSULE, GELATIN COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0642-3010-30EA - Each0642-301070f70393-81d2-4a80-aa32-9fbb2df095f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0RREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
CopperACTIVE INGREDIENT789U1901C5REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
CyanocobalaminACTIVE INGREDIENTP6YC3EG204REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Folic AcidACTIVE INGREDIENT935E97BOY8REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
IodineACTIVE INGREDIENT9679TC07X4REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
IronACTIVE INGREDIENTE1UOL152H7REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
MagnesiumACTIVE INGREDIENTI38ZP9992AREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
NiacinACTIVE INGREDIENT2679MF687AREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Omega-3 Fatty AcidsACTIVE INGREDIENT71M78END5SREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
RiboflavinACTIVE INGREDIENTTLM2976OFRREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919XREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Vitamin AACTIVE INGREDIENT81G40H8B0TREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Vitamin DACTIVE INGREDIENT9VU1KI44GPREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Vitamin EACTIVE INGREDIENTH4N855PNZ1REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
ZincACTIVE INGREDIENTJ41CSQ7QDSREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Alpha-TocopherolACTIVE MOIETYH4N855PNZ1REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0RREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Beta CaroteneACTIVE MOIETY01YAE03M7JREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
CholecalciferolACTIVE MOIETY1C6V77QF41REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Cupric OxideACTIVE MOIETYV1XJQ704R4REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
CyanocobalaminACTIVE MOIETYP6YC3EG204REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
DoconexentACTIVE MOIETYZAD9OKH9JCREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Folic AcidACTIVE MOIETY935E97BOY8REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
IodineACTIVE MOIETY9679TC07X4REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
IronACTIVE MOIETYE1UOL152H7REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Magnesium OxideACTIVE MOIETY3A3U0GI71GREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
NiacinamideACTIVE MOIETY25X51I8RD4REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
PyridoxineACTIVE MOIETYKV2JZ1BI6ZREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
RiboflavinACTIVE MOIETYTLM2976OFRREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
ThiamineACTIVE MOIETYX66NSO3N35REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Ascorbyl palmitateINACTIVE INGREDIENTQN83US2B0NREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
CaramelINACTIVE INGREDIENTT9D99G2B1RREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Corn OilINACTIVE INGREDIENT8470G57WFMREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM62REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Sodium ThiosulfateINACTIVE INGREDIENTHX1032V43MREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Soybean OilINACTIVE INGREDIENT241ATL177AREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Sunflower OilINACTIVE INGREDIENT3W1JG795YIREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
TocopherolINACTIVE INGREDIENTR0ZB2556P8REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2VREAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0642-3010REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1Legacy NDC, 2 package rows20111205_8896031e-7cb4-4376-84b1-97eae5015ec4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0642-3010-30006423010305 in 1 BOXHistorical