Cold and Flu
- Product NDC
- 42507-522
- Requested package NDC
- 42507-522-40
- 11-digit product format
- 425070522
- Labeler code
- 42507
- Product ID
- 42507-522_e865c4c1-a9a6-47c8-bcbb-2b1f3bec8a25
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-10
- 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
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
- Cold and Flu
- 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 |
|---|---|
| d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-522-30 | Cold and Flu | 177 mL in 1 BOTTLE | SOLUTION | 177 | 7 | |
| 42507-522-34 | Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 7 | |
| 42507-522-38 | Cold and Flu | 296 mL in 1 BOTTLE | SOLUTION | 296 | 7 | |
| 42507-522-40 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 7 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Preferred Pharmaceuticals Inc. | da148c1d-e394-4367-83e0-533469501b30 | 2026-04-06 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | TOP CARE (Topco Associates LLC) | b2ebfeb3-e248-40bf-81d3-81c5fb532dbe | 2026-04-06 | Warnings | M012 |
| Allergy Plus Sinus Relief | DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | Rite Aid Corporation | 54623e2e-5f9a-426e-8f7e-ea755ff8b3f8 | 2026-04-06 | Warnings | M012 |
| Cold and Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DOLGENCORP, LLC | b55452e1-25d0-4db5-9621-83f21ec6c298 | 2026-04-06 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Strategic Sourcing Services LLC | c9fa8d93-d9d6-4206-a13d-32b9e7555e7f | 2026-04-02 | Warnings | M012 |
| Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 6aaed3fe-ce35-4533-aea4-80096ce8e57a | 2026-04-02 | Warnings | M012 |
| Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 19879fc8-4962-4c6e-87ed-b874d1d564af | 2026-04-01 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Lidl US LLC | 7227b330-590b-4731-8a58-e05a0233dd8a | 2026-04-01 | Warnings | M012 |
| SudoGest | CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9 | 2026-04-01 | Warnings | M012 |
| Sanatos Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 4c26be18-733a-e4a8-e063-6294a90a8b02 | 2026-04-01 | Warnings | M012 |
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Method Pharmaceuticals, LLC | fe126254-6ee6-48c3-965c-96e4276a5314 | 2026-04-01 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief | GUAIFENESIN | AmerisourceBergen Drug Corp | 200dddd9-e3ff-4cec-a164-d1c9a698f121 | 2026-03-31 | Warnings | M012 |
| Head and Cold | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Hi-Tech Nutraceuticals, LLC | a39c772b-3cce-14cb-e053-2a95a90a733b | 2026-03-31 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 44217a8c-7656-a0f6-e063-6294a90af2ad | 2026-03-31 | Warnings | M012 |
| Dr Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CalmCo LLC | 3f156679-7a91-aff1-e063-6394a90a18f6 | 2026-03-31 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | A-S Medication Solutions | c26da6e0-ab1c-46c2-acf5-0074958c03cd | 2026-03-31 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8e0c6f8d-559c-45de-9362-1b713fd78a7a | 2026-03-30 | Warnings | M012 |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | 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 | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-522-40 | 42507052240 | 355 mL in 1 BOTTLE (42507-522-40) | 355 ml | 2014-01-10 | No | No | Current |