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 table
Ingredient	Strength
EPHEDRINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NLJ6390P1Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2534871	Internal RxNorm lookup
2591390	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2170f081-c03f-47e8-bc63-4052c5e653fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-600	PRIMATENE (EPHEDRINE HYDROCHLORIDE) TABLET [FOUNDATION CONSUMER BRANDS]	2	Current NDC, Legacy NDC, 4 package rows	20241109_2170f081-c03f-47e8-bc63-4052c5e653fa.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.

Matched openFDA labels page 163 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	dbfb8971-a122-4a97-a665-e3f0d494876e	2024-05-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012
NASAL and SINUS DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	JHK Inc dba American Safety & First Aid	63e51305-2575-49c4-9fda-7b3e1b4b6ede	2024-04-26	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NLJ6390P1Z	EPHEDRINE HYDROCHLORIDE	50-98-6	EPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
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