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 |
|---|---|---|---|---|---|---|
| Allegra Allergy 24 hour | FEXOFENADINE HYDROCHLORIDE | Select Consumer Group | 2de81a41-8488-7e39-e063-6294a90a394b | 2026-06-01 | Warnings | M012 |
| Cough and Runny Nose Childrens Plus | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | TOP CARE (Topco Associates LLC) | 6f04bd51-093c-4624-aef3-0145ac387386 | 2026-06-01 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | 694a3116-1b75-42cd-bbcf-d19831c2d796 | 2026-06-01 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | cf31538c-9eee-4c81-80cb-66eecabf0aff | 2026-06-01 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 155e07b3-0a08-3be8-e063-6394a90a7635 | 2026-05-31 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Nighttime | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 156033ae-b16a-007b-e063-6294a90a7445 | 2026-05-31 | Warnings | M012 |
| Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | ebf8c82d-a653-4c02-893b-61704901acbb | 2026-05-29 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Amerisource Bergen | 934c7b91-3cba-47f0-8efa-77216f3f15c4 | 2026-05-29 | Warnings | M012 |
| Allergy Medicine | DIPHENHYDRAMINE HCL | COSTCO WHOLESALE CORPORATION | d9f03e11-d11f-43ee-8ed0-9e07d1058f66 | 2026-05-29 | Warnings | M012 |
| Cold Childrens, Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d | 2026-05-29 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 3598ac5b-29f9-f002-e063-6294a90a62cb | 2026-05-28 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 51badd2f-4a43-3dbe-e063-6294a90a4bd1 | 2026-05-28 | Warnings | M012 |
| Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | a7ab2140-de09-158f-e053-2a95a90a25a0 | 2026-05-28 | Warnings | M012 |
| Kids Multi Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Genexa Inc. | 2d918ec8-3098-1d09-e063-6294a90a9e8f | 2026-05-28 | Warnings | M012 |
| Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Genexa Inc. | 213fe898-dace-9a0f-e063-6394a90afd64 | 2026-05-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Lemon Flavor | MENTHOL | Medical Group Care LLC | 556628ab-e233-92fe-e063-6394a90a0090 | 2026-05-28 | Warnings | M012 |
| Sinus Decongestion PE | PHENYLEPHRINE HCL | Kroger Company | 68eff734-177e-4999-9126-6b92bb204107 | 2026-05-28 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | ARMY AND AIR FORCE EXCHANGE SERVICE | ff39084f-ab2f-48ed-ac62-837f7fff2b65 | 2026-05-28 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group LLC | 52c5fda0-c358-72e8-e063-6394a90a3f68 | 2026-05-27 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 16637d54-8049-d3ce-e063-6394a90aafc9 | 2026-05-27 | 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 |