MedPath

Allergy Relief

Foster and Thrive 44-190

Approved
Approval ID

5d628b09-c257-4369-8ddb-47554d83c0d8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1015
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (13)

DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Principal Display Panel

NDC 70677-1015-1

COMPARE TO BENADRYL® ACTIVE INGREDIENT*

Foster & Thrive ™

Allergy Relief

Diphenhydramine HCl, 25 mg
** ANTIHISTAMINE**

Relief of:
****• Sneezing
• Runny Nose
• Itchy Throat
• Itchy, Watery Eyes

ACTUAL SIZE

24 CAPSULES

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
** OR IF BLISTER UNIT IS TORN OR BROKEN OR IF**
** RED BAND AROUND CAPSULE IS BROKEN OR MISSING**

*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Benadryl®.

50844 REV1117A19008 Rev.11/23

©2023 McKesson Corporation

Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC., Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com

![Foster & Thrive 44-190](/dailymed/image.cfm?name=foster-and- thrive-44-190-1.jpg&id=895951)

Foster & Thrive 44-190

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/3/2025

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/3/2025

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/3/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 9/3/2025

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/3/2025

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/3/2025

Other information

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/3/2025

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/3/2025

Questions or comments?

Call** 833-358-6431**
****Monday to Friday 9:00am to 7:00pm EST

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Allergy Relief - FDA Drug Approval Details