DayTime
- Product NDC
- 37808-656
- 11-digit product format
- 378080656
- Labeler code
- 37808
- Product ID
- 37808-656_1064a193-f147-4611-9579-858580903f2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- H E B
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-08-02
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 37808-656 | 37808-656-38 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Listing expiration
- 2027-12-31
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 |
|---|---|
| e2994c0f-add8-4f75-a6d2-24cd2af271e4 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-656-38 | DayTime | 296 mL in 1 BOTTLE | SOLUTION | 296 | 10 | |
| 37808-656-40 | DayTime | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | American Health Packaging | 2fd702ea-3069-472c-b99e-c527f1375705 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Selder, S.A. de C.V. | c2b49d10-b60f-3072-e053-2a95a90af004 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 1db914d3-8bba-405e-9bf9-9b1a5806284c | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 |
| Cough and Cold XL3 Xtra | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 38e70a28-eff2-4a48-b829-8cd68e80beef | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Midway Importing Inc. | c2c8bd26-bbf1-c2e6-e053-2995a90a86a7 | 2024-10-17 | Warnings | M012 |
| Antiflu Des Cough and Flu | ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE | Productos Farmaceuticos, S.A. de C.V. | dcf3897a-a793-6df7-e053-2995a90a25f8 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | ec6aef90-ece1-4fe6-e053-2995a90a9310 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Cold, Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | c8eebe64-00bf-436d-a9fc-1623401bebfa | 2024-10-16 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 4f42c8d2-0538-4bcd-aac0-e26103a30499 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | 9ac3e24a-d18a-48fc-8005-55393085d57b | 2024-10-16 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 45471fdd-c4cd-46ad-a932-aa37327e8a41 | 2024-10-16 | Warnings | M012 |
| DG Health Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8cb15a8d-c836-4167-bc6b-dd20a34076e8 | 2024-10-16 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | f4497e56-c69d-4ae9-bd81-80bf2ee1b17f | 2024-10-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 8256c1fb-683d-56ab-e053-2a91aa0ac197 | 2024-10-15 | Warnings | M012 |
| SINUS SEVRE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f9586e3-a8b4-4060-e053-2995a90aa068 | 2024-10-15 | 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 | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 10 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 10 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 10 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 10 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37808-656-38 | 37808065638 | 296 mL in 1 BOTTLE (37808-656-38) | 296 ml | 2006-08-02 | 0000-00-00 | No | No | Current |
| 37808-656-40 | 37808065640 | 355 mL in 1 BOTTLE (37808-656-40) | 355 ml | 2012-07-20 | 0000-00-00 | No | No | Current |