Primatene
- Product NDC
- 80070-600
- 11-digit product format
- 800700600
- Labeler code
- 80070
- Product ID
- 80070-600_2657d074-46cb-bc95-e063-6294a90aeec8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- EPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Foundation Consumer Brands
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-22
- Substance
- EPHEDRINE HYDROCHLORIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-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
- Primatene
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EPHEDRINE HYDROCHLORIDE | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| NLJ6390P1Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2170f081-c03f-47e8-bc63-4052c5e653fa | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1bd959e-e326-44fb-b8ca-8c56a84a2a3d | Product name | 2 | 20251211 |
| f1d178e1-1663-4c63-ae37-62a1b322fba4 | Product name | 2 | 20251106 |
| f606d3ac-dd63-4b29-bea0-db23753b8ddc | Product name | 1 | 20220118 |
| 30254138-2d98-4aa2-8e07-ae82e8b0a389 | Product name | 3 | 20171103 |
| fee762de-ffd9-404d-8bc6-8c0c208e758d | Product name | 1 | 20170426 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80070-600-24 | Primatene | 2 in 1 CARTON | TABLET | 2 | 2 | |
| 80070-600-24 | Primatene | 12 in 1 BLISTER PACK | TABLET | 12 | 2 | |
| 80070-600-60 | Primatene | 12 in 1 BLISTER PACK | TABLET | 12 | 2 | |
| 80070-600-60 | Primatene | 5 in 1 CARTON | TABLET | 5 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | Warnings | M012 |
| equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 3862aaa5-2281-e8f9-e063-6294a90a0f7e | 2025-09-09 | Warnings | M012 |
| McKesson Sugar Free Cough Suppressant Oral Anesthetic | MENTHOL LOZENGE | McKesson Medical-Surgical | e0dfa6ca-b311-25cb-e053-2a95a90a12cc | 2025-09-09 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e648f017-9e30-df6c-e053-2995a90adcd0 | 2025-09-09 | Warnings | M012 |
| Medi-First Honey Lemon Cough Drops | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 826e1b87-e5a9-8637-e053-2991aa0aded1 | 2025-09-09 | Warnings | M012 |
| Unishield Cherry Cough | MENTHOL | Unishield | b8297bc1-44b2-3de0-e053-2995a90ad01b | 2025-09-09 | Warnings | M012 |
| McKesson Cough Supressant | MENTHOL | McKesson Medical-Surgical | db5e0490-2ed8-2d53-e053-2a95a90a98f5 | 2025-09-09 | Warnings | M012 |
| Duratuss AC | CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 3e5ed178-d5d9-b8d4-e063-6394a90a91db | 2025-09-09 | Warnings | M012 |
| Rompe Pecho CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Efficient Laboratories Inc | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 57c458ed-7987-453b-ab24-bbfa6580f920 | 2025-09-09 | Warnings | M012 |
| equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 38637189-d1ee-9405-e063-6394a90ae8b8 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | fd52d8d8-7cd1-4e92-86da-354a1d5213c2 | 2025-09-08 | Warnings | M012 |
| Green Guard Advanced Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e8e5fb21-a7fd-44d1-b9c4-83e949699ca6 | 2025-09-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2534871 | ePHEDrine HCl 12.5 MG Oral Tablet | PSN | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
| 2591390 | Primatene with ePHEDrine 12.5 MG Oral Tablet | PSN | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
| 2591390 | ephedrine hydrochloride 12.5 MG Oral Tablet [Primatene with ephedrine] | SBD | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
| 2534871 | ephedrine hydrochloride 12.5 MG Oral Tablet | SCD | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
| 2534871 | ephedrine HCl 12.5 MG Oral Tablet | SY | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
| 2591390 | Primatene with ephedrine 12.5 MG Oral Tablet | SY | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80070-600-24 | 80070060024 | 2 BLISTER PACK in 1 CARTON (80070-600-24) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2021-01-22 | 0000-00-00 | No | No | Current |
| 80070-600-60 | 80070060060 | 5 BLISTER PACK in 1 CARTON (80070-600-60) / 12 TABLET in 1 BLISTER PACK | 5 blister pack | 2021-01-22 | 0000-00-00 | No | No | Current |