Medique Diphen
- Manufacturer
- Unifirst First Aid Corporation
- Effective date
- 2025-09-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 16
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves these symptoms due to hay fever or other respiratory allergies
- runny nose
- sneezing
- itching of the nose or throat
- itchy-watery eyes
Temporarily relieves these symptoms due to the common cold
- runny nose
- sneezing
Warnings
Warnings
OTC - DO NOT USE SECTION
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one that is used on skin.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- marked drowsiness may occur
- avoid alcohol beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health professional before use.
Keep out of the reach of children.
In case of overdose, contact a physician or poison control center right away (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
- take every 4-6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
Adults and children: (12 years and over) 1 to 2 caplets
Children under 12 years: do not use
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature 68º-77ºF (20º-25ºC)
- protect from light
- tamper-evident sealed packets
- do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? 1-800- 634-7680
184R Medique Diphen Label
Collect MediBucks See inside flap for more details
Medique®
Diphen
Hay Fever / Allergies
Fiebre del Heno / Alergias
This Package is for Households without Young Children.
Este Paquete Es Para Hogares Sin Ninos Pequenos.
Antihistamine • Diphenhydramine HCl 25 mg
Antihistaminico • Hidrocloruro de Difenhidramina 25mg
200 Caplets
(200 x 1)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
Medique 167 Diphen Principal Display Panel
Collect MediBucks See inside flap for more details
Medique®
Diphen
Hay Fever / Allergies
Fiebre del Heno / Alergias
This Package is for Households without Young Children.
Este Paquete Es Para Hogares Sin Ninos Pequenos.
Antihistamine • Diphenhydramine HCl 25 mg
Antihistaminico • Hidrocloruro de Difenhidramina 25mg
200 Caplets
(200 x 1)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-167-32 | Medique Diphen | 12 in 1 BOX | TABLET, FILM COATED | 12 | 16 | |
| 47682-167-32 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-167-46 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-167-47 | Medique Diphen | 200 in 1 BOX | TABLET, FILM COATED | 200 | 16 | |
| 47682-167-64 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-167-64 | Medique Diphen | 24 in 1 BOX | TABLET, FILM COATED | 24 | 16 | |
| 47682-184-32 | Medique Diphen | 12 in 1 BOX | TABLET, FILM COATED | 12 | 16 | |
| 47682-184-46 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-184-47 | Medique Diphen | 200 in 1 BOX | TABLET, FILM COATED | 200 | 16 | |
| 47682-184-47 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-184-64 | Medique Diphen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 16 | |
| 47682-184-64 | Medique Diphen | 24 in 1 BOX | TABLET, FILM COATED | 24 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47682-184-47 | EA - Each | 47682-184 | 9ad23d3d-85f4-4db3-893c-a0c41ee94870 | 1 | 2017-05-03 |
| 47682-184-64 | EA - Each | 47682-184 | f555f4f0-8f4c-42b5-9a60-2a44dacb1dad | 1 | 2023-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 3 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 3 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 |
Products#
Every source-derived product name is available through these pages.
- Medique Diphen
- DIPHENHYDRAMINE HYDROCHLORIDE
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- D&C RED NO. 27
- HYPROMELLOSES
- LACTOSE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- TITANIUM DIOXIDE
- DIPHENHYDRAMINE
- CARNAUBA WAX
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- POLYSORBATE 80
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-167 | 47682-167-32, 47682-167-64, 47682-167-46, 47682-167-47 |
| 47682-184 | 47682-184-46, 47682-184-32, 47682-184-64, 47682-184-47 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | POWDER, FOR SUSPENSION / ORAL | 1.67 mg/5ml | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | POWDER, FOR SUSPENSION / ORAL | 1.67 mg/5ml | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | POWDER, FOR SUSPENSION / ORAL | 1.67 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Walgreens | DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOL | Walgreen Co. | 5630f48b-404c-b847-e063-6394a90a8d8e | 2026-07-09 | Warnings | 47682-167-46 47682016746 |
| Care Science | DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOL | ASO LLC | 562f2b2c-d234-e491-e063-6294a90a705f | 2026-07-08 | Warnings | 47682-167-46 47682016746 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | 47682-167-32 47682-184-64 47682-184-47 47682-184-46 47682-167-46 47682-184-32 47682-167-64 47682-167-47 47682-167 47682-184 47682018432 47682016746 47682016747 47682018446 47682018447 47682016732 47682018464 47682016764 3e4c2097-aa05-fa04-e063-6394a90afe56 b61ee2e0-2543-447d-9fc4-23363d46ce04 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

