Indications and uses
temporarily relieves sneezing itchy nose or throat runny nose itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves sneezing itchy nose or throat runny nose itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age. specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device. children under 6 years of age do not use children 6 to under 12...
each teaspoonful contains: sodium 4 mg store at controlled room temperature 20°-25°C (68°-77°F)
NITE TIME COLD & COUGH
Drug Facts
| Active ingredients (in each 5 mL, 1 teaspoonful) | Purposes |
|---|---|
| Diphenhydramine HCl 6.25 mg | Antihistamine/Cough suppressant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| children under 6 years of age | do not use |
| children 6 to under 12 years of age | 1-2 tsp. (5-10 mL) |
artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
877-434-2036
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Nite Time
Cold & Cough
ACCURATE DOSING
BY WEIGHT
Diphenhydramine HCl
(Antihistamine/Cough Suppressant
Phenylephrine HCl
(Nasal Decongestant)
Cough Relief
Runny, Stuffy Nose
Itchy Throat
For Ages 6 to under 12
Compares to Children's
Triaminic® Night Time
Cold & Cough.
GRAPE
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-154-04

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1236048 | diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1236048 | diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1236048 | diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 1 |
| 1236048 | diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45014-154-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c7dd-621f-e053-dbdaa90a74ad | Children's ACCUDIAL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45014-154-04 | Nite Time Cold and Cough | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 45014-154 | NITE TIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.] | 1 | Legacy NDC, 1 package rows | 20091125_64dd0b21-21c5-4d45-ac7f-9896c2a033b0.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Grape | INACTIVE INGREDIENT | 6X543N684K | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 45014-154 | 45014-154-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Diphenhydramine Hydrochloride | TC2D6JAD40 | ACTIB |
| Phenylephrine Hydrochloride | 04JA59TNSJ | ACTIB |
| Grape | 6X543N684K | IACT |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Edetate Disodium | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Citrate | 1Q73Q2JULR | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Sorbitol | 506T60A25R | IACT |
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 |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAVENOUS | 396 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg |
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 |
|---|---|---|---|---|---|---|
| 2d46d37d-abad-4b65-a19c-69d843ea6662 | 64dd0b21-21c5-4d45-ac7f-9896c2a033b0 | 2009-11-11 | Warnings | 2d46d37d-abad-4b65-a19c-69d843ea6662 64dd0b21-21c5-4d45-ac7f-9896c2a033b0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.