🇺🇸
United States · US · US:55111-799_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd
Guaifenesin and Pseudoephedrine HCL
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddys Laboratories Limited
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1155111799044 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06)
- ndc1155111799121 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111799242 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111799363 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A208369
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
"match": "brand_token",
"title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "55111-799_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd",
"productndc": "55111-799",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208369",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Dec 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Dec 29, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Guaifenesin and Pseudoephedrine HCL",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208369",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Pseudoephedrine HCL",
"start_marketing_date": "20171229",
"active_numerator_strength": "1200; 120"
}Related drugs
Other records sharing ATC code R05CA.
- 🇺🇸365 Everyday Value Be Well Cough EaseWFM Private Label, LP
- 🇺🇸365 Everyday Value Be Well Cough Ease for KidsWFM Private Label, LP
- 🇺🇸Aconitum CombinationProfessional Complementary Health Formulas
- GBAdult Meltus Chesty Cough with Decongestant oral solutionSSL International Plc
- GBAdult Meltus Chesty Coughs Sugar & Colour Free oral solutionSSL International Plc
- 🇺🇸Alpha CFSchwabe North America, Inc.
- 🇺🇸ALPHA CFSchwabe Mexico, S.A. de C.V.
- 🇺🇸Always Save Mucus ReliefValu Merch
Access this data programmatically
Query Guaifenesin and Pseudoephedrine HCL and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.