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 |
|---|---|---|---|---|---|---|
| Mixed Berry Throat and Cough Lozenges | BENZOCAINE | CVS Pharmacy | 737b1c88-1a44-68cf-e053-2991aa0a35b6 | 2026-01-16 | Warnings | M012 |
| Walgreens Wild Cherry Throat Drops | PECTIN | Walgreens | 4885eca3-c1e9-8350-e063-6394a90ac290 | 2026-01-16 | Warnings | M012 |
| HBP Chest Congestion and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ff7a1462-9994-4421-85aa-c03488bb04cf | 2026-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | WALGREEN COMPANY | a793acbc-107c-4638-a2d7-65f4e96cafda | 2026-01-16 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ca53ec26-d167-1780-e053-2a95a90a5b88 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Congestion and Headache | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 88da92d2-92c2-445a-9b70-58996e086014 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 5f638bca-55c2-4ead-8c47-3f15713495da | 2026-01-16 | Warnings | M012 |
| COLD, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 190175bb-c08a-4050-aacf-29a130cbe05c | 2026-01-16 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | FSA Store Inc. (Caring Mills) | a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff | 2026-01-16 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 99147338-f459-4423-ae54-f96fffc1728d | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | 3429aedc-e83d-498a-bfca-03aaf5847b3b | 2026-01-15 | Warnings | M012 |
| Quality Choice Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 4b86101c-00f8-4ede-807f-db4273b37b8d | 2026-01-15 | Warnings | M012 |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | d1ba7267-6844-4a14-b518-65277a32e855 | 2026-01-15 | Warnings | M012 |
| ACTINEL DM Pediatric | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 2026-01-15 | Warnings | M012 |
| ACTINEL Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | ACTIPHARMA, LLC | 35c21623-84dd-4151-b35b-e7d30b69c9c0 | 2026-01-15 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | 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 |