Daytime Cold and Flu
- Product NDC
- 63868-020
- 11-digit product format
- 638680020
- Labeler code
- 63868
- Product ID
- 63868-020_da167ca4-2477-45d1-974d-f784025ca7d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-30
- Marketing end
- 2027-01-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daytime Cold and Flu
- Brand name suffix
- Non Drowsy
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| df866cf6-0526-4e61-ac9b-245b57dd5df6 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-020-08 | Daytime Cold and FluNon Drowsy | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 7 | |
| 63868-020-12 | Daytime Cold and FluNon Drowsy | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-020-08 | ML - Milliliter | 63868-020 | e7745249-c4b3-4c2f-83bd-3ec0f2ac7560 | 1 | 2018-03-08 |
| 63868-020-12 | ML - Milliliter | 63868-020 | 13afa728-907f-40f1-8d08-ee8a4a0af195 | 1 | 2018-03-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-020 | DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240423_df866cf6-0526-4e61-ac9b-245b57dd5df6.zip |
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 |
|---|---|---|---|---|---|---|
| Sinus Congestion | PHENYLEPHRINE HCL | L.N.K. International, Inc. | 81f0276a-99a2-4a57-a0d8-224735aa8c79 | 2026-07-10 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rite Aid Corporation | efaf3be1-ab39-45f7-a45c-7fea8705c8d0 | 2026-07-10 | Warnings | M012 |
| Equate Daytime Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | f847d9f2-aa47-4bbe-8f06-19356c637398 | 2026-07-10 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 2a80fba9-5e30-4ec0-bd8e-8957c0654b6c | 2026-07-10 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50230cad-3d04-8882-e063-6294a90acf3c | 2026-07-09 | Warnings | M012 |
| Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rugby Laboratories | fc42e97d-1224-4d29-a55d-1a1885e0bf8f | 2026-07-09 | Warnings | M012 |
| Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 7418d92d-a540-40d6-91d0-b7eb1f87f8ff | 2026-07-08 | Warnings | M012 |
| DG HEALTH COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d | 2026-07-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Topco Associates, LLC | bfcabe02-7961-4407-a748-8cd087731398 | 2026-07-08 | Warnings | M012 |
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | M012 |
| nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 24c22c9f-0c2f-46dc-850e-ed05f00d3e95 | 2026-07-08 | Warnings | M012 |
| NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 0e65c5d1-a18b-452c-9be6-8d44d34577e9 | 2026-07-08 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Cardinal Health 110, LLC. DBA Leader | aaecfda5-1a50-4d8a-9909-7153c1a22bda | 2026-07-08 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7cb9f378-5d64-475f-bf26-4058ba6c15b4 | 2026-07-08 | Warnings | M012 |
| DG HEALTH DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | f174d08e-3335-4cc9-8766-4070f18c4f31 | 2026-07-08 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | Health Pharma USA LLC | d60a3e9d-e88e-3b19-e053-2995a90a3e8d | 2026-07-07 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | d38f47ea-7fda-170b-e053-2995a90adc82 | 2026-07-07 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Health Pharma USA LLC | d68222f7-b796-7b27-e053-2995a90a2efe | 2026-07-07 | Warnings | M012 |
| Cold and Flu Severe Day Time / Night Time | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | acdcc6ce-c190-4de6-b126-62fe9043112e | 2026-07-07 | Warnings | M012 |
| Calmco Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 471b1a43-1708-8be7-e063-6394a90a9bb7 | 2026-07-06 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 7 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 7 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 7 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 7 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-020-08 | 63868002008 | 237 mL in 1 BOTTLE, PLASTIC (63868-020-08) | 237 ml | 2015-06-30 | 2027-01-30 | No | No | Current |
| 63868-020-12 | 63868002012 | 355 mL in 1 BOTTLE, PLASTIC (63868-020-12) | 355 ml | 2015-06-30 | 2027-01-30 | No | No | Current |