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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | e33cbd1d-1848-145a-e053-2995a90aeb50 | 2026-02-20 | Warnings | M012 |
| Head Congestion and Flu Severe Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 416080a9-e817-485b-a4ae-6c9d0152c165 | 2026-02-20 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALMART STORES INC | 18436026-b0e4-4481-a647-d735a27d0b00 | 2026-02-19 | Warnings | M012 |
| Vaporizing | CAMPHOR | Meijer, Inc. | 7afc98d7-f64f-42d5-9022-28ad6b01db8a | 2026-02-19 | Warnings, Adverse reactions | M012 |
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Kroger Company | 8196b482-070e-4d7d-8943-129141f926ee | 2026-02-19 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews Bubblegum | DIPHENHYDRAMINE HCL | WALMART STORES INC | 9f83d2f0-9718-4f2b-bc7f-e29ba2917412 | 2026-02-19 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Kroger Company | be9aaf66-6c59-4042-88e2-acd920dcf992 | 2026-02-19 | Warnings | M012 |
| Allergy Relief Dye-Free | DIPHENHYDRAMINE HCL | CVS Pharmacy | 08459cf4-feb3-4283-88e1-d61e030c57f9 | 2026-02-19 | Warnings | M012 |
| allergy relief | CHLORPHENIRAMINE MALEATE | Rite Aid Corporation | b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c | 2026-02-18 | Warnings | M012 |
| Walgreens Wild Cherry Pectin Throat Drops | PECTIN | Walgreens | 424fda2d-c1e5-0ed9-e063-6394a90a06ea | 2026-02-18 | Warnings | M012 |
| cough suppressant and topical analgesic | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Target Corporation | df21d9d6-36a9-49cf-a29c-c4a573899bd5 | 2026-02-18 | Warnings, Adverse reactions | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Amerisource Bergen | eeda80ff-212d-428e-a0c6-782f271357b4 | 2026-02-18 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | e47dffdf-5778-4804-8ce2-54c5a72bba3a | 2026-02-18 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | United Natural Foods, Inc. dba UNFI | b139e7d6-bf4d-45b9-b7cf-d34e5352095c | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Strategic Sourcing Services LLC | bd54bf7a-2304-4c3f-9cd2-bafea217466e | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Creomulsion For Children | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d0e96c-1cc3-4961-e054-00144ff88e88 | 2026-02-17 | Warnings | M012 |
| Creomulsion Cough Medicine Adult Formula | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d07486-99b7-5c06-e054-00144ff8d46c | 2026-02-17 | Warnings | M012 |
| Cold and Flu Severe, Day, Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 6e6bae79-1231-4b74-81c1-f0c914ed4af3 | 2026-02-17 | Warnings | M012 |
| COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dfe69c12-b5fe-46d1-a3bf-ef3729c2e786 | 2026-02-17 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 3fb49f64-2d77-44db-8186-5904837eedbe | 2026-02-17 | 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 |