ED A-HIST DM
- Product NDC
- 0485-0171
- 11-digit product format
- 004850171
- Labeler code
- 0485
- Product ID
- 0485-0171_4742a150-3418-b7c6-e063-6294a90adcda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- EDWARDS PHARMACEUTICALS, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-09-11
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 15; 4; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- ED A-HIST DM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/5mL |
| CHLORPHENIRAMINE MALEATE | 4 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1086443 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e0e2b117-62bc-4132-9f7c-fe2a912052b1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-01-31 | ED-EDA-HISTDM 0171 |
| 2024-01-30 | ED-EDA-HISTDM 0171 |
| 2020-04-08 | ED-EDA-HISTDM 0171 |
| 2020-01-31 | ED-EDA-HISTDM 0171 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0485-0171-16 | ED A-HIST DM | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0485-0171-16 | ML - Milliliter | 0485-0171 | ace451c0-1253-46ba-ab7a-e92a18c08ad7 | 1 | 2013-05-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0485-0171 | ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241228_e0e2b117-62bc-4132-9f7c-fe2a912052b1.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 |
|---|---|---|---|---|---|---|
| NIGHTTIME CHERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 36924420-f514-4225-e063-6294a90a330c | 2026-03-03 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 4584d701-5a4e-e54e-e063-6394a90a38d6 | 2026-03-03 | Warnings | M012 |
| foster and thrive nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Sportpharm LLC | 7bdfd2ef-bb99-41f5-97ae-3a02c994bddd | 2026-03-03 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | d27b5976-8cc0-4d99-96f6-9069b786affd | 2026-03-03 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | A-S Medication Solutions | 7f703c9c-2256-4524-9d31-c51919399d26 | 2026-03-03 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | f49f1e9a-07ac-443e-9df8-3281d5f35e78 | 2026-03-03 | Warnings | M012 |
| berkley and jensen nasal | OXYMETAZOLINE HYDROCHLORIDE | BJWC | 77cbe75d-4ed9-4a8b-91dc-1cc28af25508 | 2026-03-02 | Warnings | M012 |
| childrens cold and cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Walgreen Company | 6c7c950d-ed48-4428-9e9e-73684cabc699 | 2026-02-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Kroger Co. | 116146db-719f-4c48-8a8a-1120ea62b0d5 | 2026-02-27 | Warnings, Adverse reactions | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 1f737b76-14b5-618a-e063-6294a90a19c2 | 2026-02-27 | Warnings | M012 |
| WALGREENS NIGHTTIME ALLERGY RELIEF | DOXYLAMINE SUCCINATE | WALGREENS CO. | a3c7df98-4611-4b61-9c03-5e687364bf74 | 2026-02-27 | Warnings | M012 |
| MEIJER Childrens Allergy Relief Chews | DIPHENHYDRAMINE HCL | MEIJER DISTRIBUTION INC | 3368e081-a3b2-4c03-8bd1-05cc6af0391d | 2026-02-27 | Warnings | M012 |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | M012 |
| Tussin DM Cough and Chest | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 402969c9-945c-44b7-b018-b62f427ce571 | 2026-02-26 | Warnings | M012 |
| nasal original | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | d997f264-1b4a-4cca-a282-bd9645d55bfd | 2026-02-26 | Warnings | M012 |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | M012 |
| Cough and Chest Congestion DN, Cough DM Daytime, Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 184059b7-9238-480e-be4a-ed105f13c19d | 2026-02-25 | Warnings | M012 |
| Kids Daytime Cough and Nighttime Cough combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Genexa Inc. | 4bad39f1-86d4-b8a1-e063-6394a90a7a95 | 2026-02-25 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 67072a38-1ae7-4e59-bfed-71db0d93215d | 2026-02-25 | Warnings | M012 |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086443 | chlorpheniramine maleate 4 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | e0e2b117-62bc-4132-9f7c-fe2a912052b1 | 10 |
| 1086443 | chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | e0e2b117-62bc-4132-9f7c-fe2a912052b1 | 10 |
| 1086443 | chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | e0e2b117-62bc-4132-9f7c-fe2a912052b1 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0485-0171-16 | 00485017116 | 473 mL in 1 BOTTLE, PLASTIC (0485-0171-16) | 473 ml | 2012-09-11 | 0000-00-00 | No | No | Current |