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 |
|---|---|---|---|---|---|---|
| good sense allergy | DIPHENHYDRAMINE HCL | L. Perrigo Company | bf5039a0-2109-41a2-84a9-b5167d0a93da | 2026-07-22 | Warnings | M012 |
| Congestion and Headache | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 432c3ec4-7595-4213-94e3-ce41af91804e | 2026-07-21 | Warnings | M012 |
| SKAPEMED ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a208a1f-f6e8-0b4a-e063-6294a90a10c8 | 2026-07-21 | Warnings | M012 |
| SERYNTH FAST RELIEF NASAL | NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4abdc0-aded-1b8a-e063-6394a90a9b56 | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d0c03-7d8f-76cb-e063-6394a90a938c | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL 0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d3a2b-a4ed-c736-e063-6394a90a96df | 2026-07-21 | Warnings | M012 |
| Severe Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 791eaac1-ddb5-40e2-9040-52dfadc30e06 | 2026-07-21 | Warnings | M012 |
| DRx Choice DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc. | 9ab47b10-b1ed-4ae1-94e8-09d50e952bb0 | 2026-07-21 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 17639c3b-5d36-41f5-bd0d-da29075abd09 | 2026-07-21 | Warnings | M012 |
| NATUHEAL ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a470b9e-c83f-fb20-e063-6294a90a2f13 | 2026-07-20 | Warnings | M012 |
| TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1c444202-19e9-8d04-e063-6394a90a9294 | 2026-07-20 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 5565a581-e2b5-81a5-e063-6394a90af409 | 2026-07-20 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 40e0b17a-5704-4203-8f0a-11b2fcf81f8f | 2026-07-17 | Warnings | M012 |
| Equate Daytime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | ee1ef41d-b8be-42f3-9918-ccf1c0a80241 | 2026-07-17 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 95007785-ddf6-4386-af5f-84dac1066b40 | 2026-07-17 | Warnings | M012 |
| BEST CHOICE No Drip | ALLERGY SINUS | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d5f95b56-8201-4d97-82ab-e23761bfe720 | 2026-07-17 | Warnings | M012 |
| Best Choice Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 7d19fdba-35b0-424a-ba11-315521d3256d | 2026-07-17 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | badb15ac-91e8-4962-96f5-beb250977560 | 2026-07-17 | Warnings | M012 |
| Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0839c07b-f692-4af1-85b8-da60fb281d49 | 2026-07-17 | 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 |