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 |
|---|---|---|---|---|---|---|
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | M012 |
| Childrens Dye Free Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 1c4d09ed-4e0f-430d-b17f-6a23f996a55d | 2024-04-15 | Warnings | M012 |
| Theraflu ExpressMax Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 2024-04-10 | Warnings | M012 |
| Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 2024-04-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Harris Teeter, LLC | ec603195-eb36-4b5c-bc9b-c2074205b2b2 | 2024-04-09 | Warnings | M012 |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 2024-04-09 | Warnings | M012 |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | M012 |
| ROBITUSSIN COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 4908b326-e1da-44ca-8087-7e41a16c27b0 | 2024-04-08 | Warnings | M012 |
| Robitussin Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | H E B | 9ba5ca1b-2e3c-439e-8887-c26f144b88ef | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | M012 |
| Allergy Childrens | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | ab28cbc4-7a6f-46e9-8616-be78e8cb24fe | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | M012 |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | M012 |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | M012 |
| Robitussin Peak Cold Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 8c0a2424-e8ac-d91c-b46d-a5ee29f91936 | 2024-04-06 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5 | 2024-04-06 | 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 |