S2

Product NDC: 0487-5901
11-digit product format: 004875901
Labeler code: 0487
Product ID: 0487-5901_495453e6-2060-edaa-e063-6394a90a8a5d
Type: HUMAN OTC DRUG
Nonproprietary name: racepinephrine hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Nephron Pharmaceuticals Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-01-01
Substance: RACEPINEPHRINE HYDROCHLORIDE
Active strength: 11.25 mg/.5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: S2
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RACEPINEPHRINE HYDROCHLORIDE	11.25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
336096P2WE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310133	Internal RxNorm lookup
863968	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
dd1b35c7-b23b-4b95-8162-df3d263fe32e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0487-5901-99	S2	30 in 1 CARTON	SOLUTION	30		12
0487-5901-99	S2	1 in 1 POUCH	SOLUTION	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0487-5901-02	EA - Each	0487-5901	e4fa89c2-def9-4c41-9c97-ccaf02f5b5cf	1	2012-07-24
0487-5901-10	EA - Each	0487-5901	4e462d6e-f2d0-4ea7-bcfa-2073e6f5109f	1	2013-02-13
0487-5901-99	EA - Each	0487-5901	530e7c42-5bd7-483e-96d6-682b76349b33	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RACEPINEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	336096P2WE	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
RACEPINEPHRINE	ACTIVE MOIETY	GR0L9S3J0F	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0487-5901	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20241222_dd1b35c7-b23b-4b95-8162-df3d263fe32e.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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold Cough and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	a35531d7-1a96-45cb-922f-61db085cde1f	2026-06-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	5fe9f313-d6e7-41f5-abfc-e4c72b708961	2026-06-15	Warnings	Exact identifier application number: M012
Pain Relief Sinus Congestion	ACETAMINOPHEN, PHENYLEPHRINE HCL	Better Living Brands, LLC	1d3d6397-0d92-4145-9a70-8bcc45bd0322	2026-06-15	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d5d9334d-3db6-4f45-ab84-3e1ec5a752c6	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Geiss, Destin & Dunn Inc.	fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b	2026-06-15	Warnings	Exact identifier application number: M012
equate daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	983a4783-d826-41b6-8087-ca66bcd5b6ca	2026-06-12	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	4173ecde-a2d7-4836-a6e9-fef2270d1b4e	2026-06-12	Warnings	Exact identifier application number: M012
PAIN RELIEVER PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	cf370a59-42d5-42fe-882f-09885c55f570	2026-06-11	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion Plus Cold Severe Day	ACETAMINOPHEN, PSEUDOEPHEDRINE	Kenvue Brands LLC	537e1a0d-820d-c3f7-e063-6294a90a56ea	2026-06-10	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and Night	ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE	Kenvue Brands LLC	5382dcad-0337-4440-e063-6394a90a706e	2026-06-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	21cfa71c-7a8f-4100-a42e-9190260653d1	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	WALGREENS	47f1d92f-cb4b-1635-e063-6294a90a2c71	2026-06-09	Warnings	Exact identifier application number: M012
HALLS Honey	MENTHOL	Mondelez Global LLC	837f5ded-8efb-402b-a1bc-b5c142755660	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	932b11b1-f4a0-417a-bfa1-05261a172155	2026-06-08	Warnings	Exact identifier application number: M012
NO DRIP NASAL MIST	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	957efbcf-b6d3-4793-bb6e-27e99c9be905	2026-06-08	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	493caecb-e687-49ea-b7a1-2a5b9376896d	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	4ad10fd7-c088-4356-9d34-a95cfe3a4133	2026-06-08	Warnings	Exact identifier application number: M012
Theraflu Severe Congestion Relief Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	4ec42064-7390-4137-a93e-57343c3c76a7	2026-06-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
336096P2WE	RACEPINEPHRINE HYDROCHLORIDE	329-63-5	RACEPINEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310133	racepinephrine 2.25 % Inhalation Solution	PSN	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2, 2.25 % Inhalation Solution	PSN	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	racepinephrine 22.5 MG/ML Inhalation Solution [S-2]	SBD	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 22.5 MG/ML Inhalation Solution	SCD	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 11.25 MG per 0.5 ML Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 2.25 % Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2 11.25 MG (racepinephrine hydrochloride 13.5 MG) per 0.5 ML Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2 2.25 % Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0487-5901-99	00487590199	30 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE	30 pouch	2000-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Racepinephrine Inhalation Solution, USP 2.25%	Nephron Pharmaceuticals Corporation \| Nephron SC, LLC	2026-01-26	HUMAN OTC DRUG LABEL	12
Racepinephrine Inhalation Solution, USP 2.25%	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN OTC DRUG LABEL	2

S2