FDA.reportPublic FDA data

DR. RECKEWEG R34 Calcossin

Manufacturer
PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO
Effective date
2013-04-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:36

Label at a glance#

ProductDR. RECKEWEG R34 Calcossin Combination Product
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE, MATRICARIA RECUTITA, HEKLA LAVA, MERCURIC OXIDE, DAPHNE MEZEREUM BARK, SILICON DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Calcarea carbonica 30X, Calcarea fluorica 12X, Calcarea hypophosphorosa 6X, Calcarea phosphorica 12X, Chamomilla 6X, Hekla Lava 12X, Mercurius praecipitatus ruber 12X, Mezereum 6X, Silicea 30X,  

1 g each in 10 g.

OTC - PURPOSE SECTION

Purpose

Relieves symptoms associated with osteoporosis in adults and bone growth in children

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor symptoms associated with osteoporosis in adults and bone growth in children such as:

  • Minor pain in bones
  • Demineralization

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • if allergic to plants of the daisy (Asteraceae/Compositae) family.

OTC - ASK DOCTOR SECTION

Ask a doctor before use

  • in children at the age of 2-11 years.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breastfeeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children ≥ 12 years 5-10 drops 1-3 times daily in a little water or undiluted or as recommended. For children (2-11 years): consult a health care professional before use.

OTHER SAFETY INFORMATION

Other information

  • Tamper resistant: do not use if safety ring at base of cap is broken.
  • Retain outer carton for full product information.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol, purified water.

OTC - QUESTIONS SECTION

Questions?

Call 1.800.361.7872 or email questions@reckeweg.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

NDC# 53346-1334-5

Dr. Reckeweg R34 Calcossin

Homeopathic preparation for the temporary relief of minor symptoms associated with osteoporosis and bone growth in children such as:

  • Minor pain in bones
  • Demineralization


Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

                                     
1.68 fl oz
(50 ml)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53346-1334-52020-01-31C16284748780-19d75b9d1-0c03-f424-e053-dadaa90a57ceDR. RECKEWEG R34 Calcossin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53346-1334-5DR. RECKEWEG R34 CalcossinCombination Product50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53346-1334DR. RECKEWEG R34 CALCOSSIN COMBINATION PRODUCT (CALCAREA CARBONICA 30X, CALCAREA FLUORICA 12X, CALCAREA HYPOPHOSPHOROSA 6X, CALCAREA PHOSPHORICA 12X, CHAMOMILLA 6X, HEKLA LAVA 12X, MERCURIUS PRAECIPITATUS RUBER 12X, MEZEREUM 6X, SILICEA 30X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1Legacy NDC, 1 package rows20130514_eaa57f2e-c76e-440a-8062-805b31f0f51f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
CALCIUM HYPOPHOSPHITEACTIVE INGREDIENTCUI83R27321
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEACTIVE INGREDIENTO7TSZ97GEP1
DAPHNE MEZEREUM BARKACTIVE INGREDIENTX2N6E405GV1
HEKLA LAVAACTIVE INGREDIENTC21158IIRK1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
MERCURIC OXIDEACTIVE INGREDIENTIY191986AO1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSACTIVE MOIETYL11K75P92J1
DAPHNE MEZEREUM BARKACTIVE MOIETYX2N6E405GV1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
HEKLA LAVAACTIVE MOIETYC21158IIRK1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
MERCURIC OXIDEACTIVE MOIETYIY191986AO1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53346-133453346-1334-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALCIUM HYPOPHOSPHITECUI83R2732ACTIR
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
HEKLA LAVAC21158IIRKACTIB
MERCURIC OXIDEIY191986AOACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3d3c578-4872-4a94-80e1-bcaf42087ed9eaa57f2e-c76e-440a-8062-805b31f0f51f2013-04-04WarningsExact identifier
spl id: b3d3c578-4872-4a94-80e1-bcaf42087ed9
spl set id: eaa57f2e-c76e-440a-8062-805b31f0f51f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.