Cold Multi-Symptom Daytime
- Product NDC
- 41520-138
- 11-digit product format
- 415200138
- Labeler code
- 41520
- Product ID
- 41520-138_2489b22e-7d05-8fdb-e063-6394a90acdb4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-09-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/1; mg/1; mg/1
- 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
- 2026-12-31
- 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
- Cold Multi-Symptom Daytime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
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 |
|---|---|
| 1094538 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d2dcbc7c-e66c-4922-83df-c706a37bf334 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41520-138-05 | Cold Multi-Symptom Daytime | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 4 | |
| 41520-138-05 | Cold Multi-Symptom Daytime | 2 in 1 CARTON | TABLET, COATED | 2 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41520-138 | COLD MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241017_d2dcbc7c-e66c-4922-83df-c706a37bf334.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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | db264d2f-bf81-4da2-8595-2bfa1e4ba2f1 | 2026-05-18 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c | 2026-05-15 | Warnings | M012 |
| good neighbor pharmacy cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | da91e6b6-32ff-44fd-afce-33ea9549554b | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | 847cdee8-410f-4ff3-9245-976ed6f4c776 | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | d3b2f300-d919-44cd-ab71-b74b5bdfd977 | 2026-05-15 | Warnings | M012 |
| ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER | ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS | MEDWISE LIFESCIENCES INC. | 51d52ce4-98c4-2b9b-e063-6294a90ade44 | 2026-05-15 | Warnings | M012 |
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Honey Lemon | MENTHOL | Melaleuca, Inc. | 84ac3489-9d64-401f-ab78-715af4de5440 | 2026-05-15 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 51e03b5b-b05a-07c1-e063-6394a90ab201 | 2026-05-15 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytime | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 38d73a1e-ac78-4f67-9291-bb48ab80306e | 2026-05-15 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALMART INC. | 071615ba-f50a-4d2a-a358-43140bccce72 | 2026-05-14 | Warnings | M012 |
| Severe Cold and Flu Nighttime Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | d4bcfabb-a054-4f53-8dc9-d361a03558b8 | 2026-05-14 | Warnings | M012 |
| Cough and Chest Congestion DM Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 4444c05a-eba6-4633-b86f-34f455699fa9 | 2026-05-14 | Warnings | M012 |
| Topcare Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 2026-05-14 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 69b24c67-cf4b-46d7-a44b-d1917cc876b1 | 2026-05-14 | Warnings | M012 |
| GILTUSS DIABETIC EX | GILTUSS DIABETIC EX | Gil Pharmaceutical Corp | ab7915e7-323a-4fe1-887a-a3bd3f0aac98 | 2026-05-13 | Warnings | M012 |
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | M012 |
| Giltuss EX Expectorant | GILTUSS EX EXPECTORANT | Gil Pharmaceutical Corp | 3b363fb9-c4d3-446f-927c-f705ffc715b5 | 2026-05-13 | Warnings | M012 |
| Giltuss HBP EX Expectorant | GILTUSS HBP EX EXPECTORANT | Gil Pharmaceutical Corp | 31bd6356-27cf-4188-8fd5-9cd9392021ca | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094538 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | d2dcbc7c-e66c-4922-83df-c706a37bf334 | 4 |
| 1094538 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | d2dcbc7c-e66c-4922-83df-c706a37bf334 | 4 |
| 1094538 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | d2dcbc7c-e66c-4922-83df-c706a37bf334 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41520-138-05 | 41520013805 | 2 BLISTER PACK in 1 CARTON (41520-138-05) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2011-09-01 | 0000-00-00 | No | No | Current |