FDA.reportPublic FDA data

Dimetapp

Manufacturer
Foundation Consumer Healthcare
Effective date
2024-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:10

Label at a glance#

ProductDimetapp Nighttime Cold and Cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever (or other respiratory allergies) relieves the impluse to cough to help you sleep

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use

Storage and handling

each 10 mL contains: sodium 8 mg store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each 10 mL)Purpose
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • cough
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other respiratory allergies)
  • relieves the impluse to cough to help you sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • mL = milliliter
agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 8 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Distributed by:
Foundation Consumer Healthcare, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA

CHILDREN'S
Dimetapp ®

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHARMACIST
RECOMMENDED

Nighttime
Cold &
Cough

Relieves + comforts:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

6+
YRS

4 FL OZ
(118 mL)

Grape Flavor • Alcohol Free

Dimetapp 4oz CartonDimetapp 4oz Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN1
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD1
1049884diphenhydramine hydrochloride 50 MG per 40 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850026660029GTIN-13: 0850026660029
EAN-13: 0850026660029
GTIN-12: 850026660029
UPC-A: 850026660029
GTIN storage (14 digits): 00850026660029		nighttime-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-345-04DimetappNighttime Cold and Cough1 in 1 CARTONSOLUTION11
69536-345-04DimetappNighttime Cold and Cough118 mL in 1 BOTTLESOLUTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-345DIMETAPP NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [FOUNDATION CONSUMER HEALTHCARE]1Current NDC, 2 package rows20240601_179115ad-d610-99b2-e063-6294a90ae711.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-34569536-345-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
ndc (package): 69536-345-04
ndc (product): 69536-345
ndc11 (package): 69536034504
spl id: 179134da-6ed7-15b1-e063-6394a90a940f
spl set id: 179115ad-d610-99b2-e063-6294a90ae711
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
ndc (package): 69536-345-04
ndc11 (package): 69536034504
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
ndc (package): 69536-345-04
ndc11 (package): 69536034504

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.