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 |
|---|---|---|---|---|---|---|
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 3dc293c9-736b-4bd8-b993-ff83b9909bcd | 2024-02-23 | Warnings | M012 |
| Childrens Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health (Leader) 70000 | 10cc7d67-30c4-4451-bf74-78abae3c8e25 | 2024-02-23 | Warnings | M012 |
| Nasal Spray, 24-7 for Life | OXYMETAZOLINE HYDROCHLORIDE 0.05% | Lil' Drug Store Products, Inc. | 11d27c75-fd95-f9da-e063-6394a90ac6b0 | 2024-02-20 | Warnings | M012 |
| Nighttime Cold and Cough childrens | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 11652e8a-2242-4449-8a41-a8e75509025e | 2024-02-20 | Warnings | M012 |
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | 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 |