FDA.reportPublic FDA data

dg health nasal four

Product NDC
55910-802
11-digit product format
559100802
Labeler code
55910
Product ID
55910-802_153b975f-24d9-4112-b612-68f2cacd40c9
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Dolgencorp, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-16
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 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
dg health nasal four
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087043Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ceeeb016-8e46-40b8-9923-8a4270475f45Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-802-10dg health nasal four29.6 mL in 1 BOTTLE, SPRAYSPRAY29.62
55910-802-10dg health nasal four1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-802DG HEALTH NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]2Current NDC, Legacy NDC, 2 package rows20241006_ceeeb016-8e46-40b8-9923-8a4270475f45.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 139 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo Foods Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEWinCo Foods, LLCd443a030-d3d6-40e0-8fe0-329de6bc494f2024-11-13WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Company954fe703-9a10-4354-8b71-4d98a22a0b9f2024-11-13WarningsExact identifier
application number: M012
NASAL DECONGESTANT PEPHENYLEPHRINE HCLA-S Medication Solutions9d030767-dfd6-48b4-9b17-4e20c23915f32024-11-13WarningsExact identifier
application number: M012
Childrens SUDAFED PE Cold plus CoughDEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC20e45243-3989-413a-bcf1-49d754ff2e442024-11-12WarningsExact identifier
application number: M012
Tukol Cough And Cold Honey FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAa4b333dc-58da-45db-87b6-6fcb8fb542b82024-11-12WarningsExact identifier
application number: M012
daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company4b49137c-8fc9-43b7-b1a1-82e318237eb62024-11-12WarningsExact identifier
application number: M012
CVS Original Nasal MistOXYMETAZOLINE HCLCVS PHARMACY, INCe9c551a0-cd78-4272-b42f-36c096d267362024-11-12WarningsExact identifier
application number: M012
up and up cough plus chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINTarget Corporationed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c2024-11-12WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Incb33d104b-0b4d-40c6-8345-c2c7403273312024-11-11WarningsExact identifier
application number: M012
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerican Sales Company6c90fccf-0e6f-43df-9468-d8ece8ded0092024-11-11WarningsExact identifier
application number: M012
good sense night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company89dc1423-d097-47a8-9025-eab5381cca262024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC10f9627b-edda-422a-b01f-7066f9c983352024-11-11WarningsExact identifier
application number: M012
nighttime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED17c3fe42-3c40-4405-80b7-b3f9e4aa83762024-11-11WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B1dd36aa7-f085-4350-8cf2-f9fa29b583e42024-11-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7f9f1d0-7498-461c-b4e8-4c92cf3feae82024-11-11WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreen Companybd079f5d-0a38-40e6-9661-e8236c88a24d2024-11-11WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCe1118592-30ac-4505-9f38-c6d395c4cf5b2024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSNceeeb016-8e46-40b8-9923-8a4270475f452
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCDceeeb016-8e46-40b8-9923-8a4270475f452
1087043phenylephrine hydrochloride 1 % Nasal SpraySYceeeb016-8e46-40b8-9923-8a4270475f452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-802-10559100802101 BOTTLE, SPRAY in 1 CARTON (55910-802-10) / 29.6 mL in 1 BOTTLE, SPRAY2021-06-160000-00-00NoNoCurrent