FDA.reportPublic FDA data

FOSTER AND THRIVE ALL DAY ALLERGY D

Product NDC
70677-1311
11-digit product format
706771311
Labeler code
70677
Product ID
70677-1311_7f629526-b23f-45e8-a6fd-b290f2a278d1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride, Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA210719
Marketing category
ANDA
Marketing start
2025-12-10
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FOSTER AND THRIVE ALL DAY ALLERGY D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA, 6V9V2RYJ8N
Rxcui1014571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1311-1FOSTER AND THRIVE ALL DAY ALLERGY D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
70677-1311-1FOSTER AND THRIVE ALL DAY ALLERGY D12 in 1 CARTONTABLET, FILM COATED, EXTENDED RE122
70677-1311-2FOSTER AND THRIVE ALL DAY ALLERGY D24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE242
70677-1311-2FOSTER AND THRIVE ALL DAY ALLERGY D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1311-1EA - Each70677-1311ccfca96a-6181-430d-b3e0-8dcba16f925c12026-02-05
70677-1311-2EA - Each70677-1311de77cb84-de9e-4f1c-8ca6-50e22071817a12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN796bea75-847a-40cd-892c-0905caae5c4e2
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD796bea75-847a-40cd-892c-0905caae5c4e2
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY796bea75-847a-40cd-892c-0905caae5c4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1311-17067713110112 BLISTER PACK in 1 CARTON (70677-1311-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK12 blister pack2025-12-10NoNoHistorical
70677-1311-27067713110224 BLISTER PACK in 1 CARTON (70677-1311-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2025-12-10NoNoHistorical